17 Academic Researchers jobs in Raleigh
Clinical Research Associate (REMOTE)
27560 Morrisville, North Carolina
Teleflex
Posted 1 day ago
Job Viewed
Job Description
Clinical Research Associate (REMOTE)
**Date:** Jul 18, 2025
**Location:** Morrisville, NC, US
**Company:** Teleflex
**Expected Travel** : Up to 25%
**Requisition ID** :12473
**About Teleflex Incorporated**
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** .
**Interventional -** The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
**Position Summary**
The Clinical Research Associate (CRA) facilitates clinical investigations, builds relationships, and communicates results. Responsibilities span all phases of clinical studies, including initiation, enrollment, data analysis, and closure.
The CRA designs case report forms, monitoring plans, and study documents; manages data; performs monitoring; maintains study files; and supports site coordinators and investigators. They ensure compliance with regulations and policies, mentor junior staff, and lead projects.
**Principal Responsibilities**
- Manage sites from start-up to closure.
- Identify and resolve logistical and operational issues.
- Conduct site training.
- Perform on-site, remote, and centralized monitoring.
- Assist with protocol design and data collection methods.
- Develop and review essential study documents.
- Ensure compliance with FDA and Teleflex requirements.
- Oversee in-house study files and audit for compliance.
- Assist with IRB submissions and renewals.
- Maintain professional relationships with investigators and sites.
- Recognize and resolve data discrepancies and compliance issues.
- Report serious compliance issues and implement corrective actions.
- Review data for completeness and accuracy.
- Assist in writing FDA submissions and clinical reports.
- Develop and implement study-specific databases.
- Support study operations and communication with committees.
- Provide input for new projects and departmental policies.
- Anticipate and address study conduct issues.
- Create and resolve queries and action items.
- Complete and review Monitoring Visit Reports and Follow-up Letters.
- Support team members in other trials.
- Adhere to departmental SOPs and escalate discrepancies.
**Education / Experience Requirements**
- Bachelor's or Graduate degree in life sciences, nursing or other health related disciplines.
- Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO.
**Specialized Skills / Other Requirements**
- Demonstrated aptitude and knowledge in relevant therapeutic area (Electrophysiology, Vascular Interventional Cardiology and Neuromodulation) and ability to learn and integrate new or different therapeutic areas.
- Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials.
- Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is preferred.
- Demonstrated ability to independently lead study or department projects
- Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
- High attention to detail and accuracy.
- Proficient knowledge of medical terminology.
- Excellent time management and organizational skills.
- Excellent professional writing and oral communication skills.
- Excellent interpersonal skills.
- Ability to work independently as well as part of a team.
- Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
- Ability to lift 25 or more pounds.
TRAVEL REQUIRED: 25%
The pay range for this position at commencement of employment is expected to be between $105,000- $115,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-LM1
_At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._
_Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: or
_Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._
_© 2025 Teleflex Incorporated. All rights reserved._
**Date:** Jul 18, 2025
**Location:** Morrisville, NC, US
**Company:** Teleflex
**Expected Travel** : Up to 25%
**Requisition ID** :12473
**About Teleflex Incorporated**
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** .
**Interventional -** The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
**Position Summary**
The Clinical Research Associate (CRA) facilitates clinical investigations, builds relationships, and communicates results. Responsibilities span all phases of clinical studies, including initiation, enrollment, data analysis, and closure.
The CRA designs case report forms, monitoring plans, and study documents; manages data; performs monitoring; maintains study files; and supports site coordinators and investigators. They ensure compliance with regulations and policies, mentor junior staff, and lead projects.
**Principal Responsibilities**
- Manage sites from start-up to closure.
- Identify and resolve logistical and operational issues.
- Conduct site training.
- Perform on-site, remote, and centralized monitoring.
- Assist with protocol design and data collection methods.
- Develop and review essential study documents.
- Ensure compliance with FDA and Teleflex requirements.
- Oversee in-house study files and audit for compliance.
- Assist with IRB submissions and renewals.
- Maintain professional relationships with investigators and sites.
- Recognize and resolve data discrepancies and compliance issues.
- Report serious compliance issues and implement corrective actions.
- Review data for completeness and accuracy.
- Assist in writing FDA submissions and clinical reports.
- Develop and implement study-specific databases.
- Support study operations and communication with committees.
- Provide input for new projects and departmental policies.
- Anticipate and address study conduct issues.
- Create and resolve queries and action items.
- Complete and review Monitoring Visit Reports and Follow-up Letters.
- Support team members in other trials.
- Adhere to departmental SOPs and escalate discrepancies.
**Education / Experience Requirements**
- Bachelor's or Graduate degree in life sciences, nursing or other health related disciplines.
- Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO.
**Specialized Skills / Other Requirements**
- Demonstrated aptitude and knowledge in relevant therapeutic area (Electrophysiology, Vascular Interventional Cardiology and Neuromodulation) and ability to learn and integrate new or different therapeutic areas.
- Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials.
- Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is preferred.
- Demonstrated ability to independently lead study or department projects
- Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
- High attention to detail and accuracy.
- Proficient knowledge of medical terminology.
- Excellent time management and organizational skills.
- Excellent professional writing and oral communication skills.
- Excellent interpersonal skills.
- Ability to work independently as well as part of a team.
- Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
- Ability to lift 25 or more pounds.
TRAVEL REQUIRED: 25%
The pay range for this position at commencement of employment is expected to be between $105,000- $115,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-LM1
_At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._
_Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: or
_Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._
_© 2025 Teleflex Incorporated. All rights reserved._
View Now
0
Research Associate I/II - Bioscaffolds
27709 Research Triangle Park, North Carolina
United Therapeutics
Posted 13 days ago
Job Viewed
Job Description
California, US residents click here ( .
**The job details are as follows:**
**Who we are:**
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: **UTHR** ) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create bio-artificial organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
**Who you are:**
We are looking for a tissue handling and aseptic technique pro who loves spending time in the lab. This person will be comfy cozy executing tissue dissection and be bringing previous experience reviewing histological slides. This is an incredible opportunity that straddles operations and analysis and offers the opportunity for post decellularization process development and experimentation.
**RA 1 Minimum Requirements:**
+ Bachelor's Degree in life science, engineering, biomedical science
+ Knowledge of aseptic technique
+ Knowledge of fluid mechanics, physiological assessments
+ Experience with tissue handling and dissection
+ Good team member skills; must work well with others
+ Ability to initiate and manage day-to-day tasks effectively
+ Ability to organize and present data
+ Ability to independently follow experimental methods and protocols
+ Experience with word processing, spreadsheet, presentation and related standard software. Experience with laboratory instrumentation and data software.
**RA 2 Minimum Requirements:**
+ 2+ years of active industry laboratory experience in the field of regenerative medicine with a Bachelor's Degree in life science, engineering, biomedical science OR 1+ year of active industry laboratory experience in the field of regenerative medicine with a Master's Degree in life science, engineering, biomedical science
+ Demonstrated ability to efficiently perform microbiology testing, including bioburden, growth promotion, and endotoxin assessments
+ Sound understanding of statistical analysis and demonstrated ability to apply statistical tools to the analysis of complex data sets and interpret resulting statistical findings
+ Facility with appropriate word processing, spreadsheet, presentation and related standard software
+ Experience with laboratory instrumentation and data software
+ Experience with aseptic technique
**Job Location**
This is a 100% onsite role in RTP, NC
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
**The job details are as follows:**
**Who we are:**
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: **UTHR** ) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create bio-artificial organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
**Who you are:**
We are looking for a tissue handling and aseptic technique pro who loves spending time in the lab. This person will be comfy cozy executing tissue dissection and be bringing previous experience reviewing histological slides. This is an incredible opportunity that straddles operations and analysis and offers the opportunity for post decellularization process development and experimentation.
**RA 1 Minimum Requirements:**
+ Bachelor's Degree in life science, engineering, biomedical science
+ Knowledge of aseptic technique
+ Knowledge of fluid mechanics, physiological assessments
+ Experience with tissue handling and dissection
+ Good team member skills; must work well with others
+ Ability to initiate and manage day-to-day tasks effectively
+ Ability to organize and present data
+ Ability to independently follow experimental methods and protocols
+ Experience with word processing, spreadsheet, presentation and related standard software. Experience with laboratory instrumentation and data software.
**RA 2 Minimum Requirements:**
+ 2+ years of active industry laboratory experience in the field of regenerative medicine with a Bachelor's Degree in life science, engineering, biomedical science OR 1+ year of active industry laboratory experience in the field of regenerative medicine with a Master's Degree in life science, engineering, biomedical science
+ Demonstrated ability to efficiently perform microbiology testing, including bioburden, growth promotion, and endotoxin assessments
+ Sound understanding of statistical analysis and demonstrated ability to apply statistical tools to the analysis of complex data sets and interpret resulting statistical findings
+ Facility with appropriate word processing, spreadsheet, presentation and related standard software
+ Experience with laboratory instrumentation and data software
+ Experience with aseptic technique
**Job Location**
This is a 100% onsite role in RTP, NC
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
View Now
1
Clinical Research Associate, Sponsor Dedicated
27722 Durham, North Carolina
IQVIA
Posted 13 days ago
Job Viewed
Job Description
Our team is looking for Clinical Research Associates to join our Sponsor Dedicated team. Ideal candidates can be located anywhere in the US near a major airport hub. Oncology experience preferred.
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least months of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least months of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
View Now
2
Clinical Research Associate, Sponsor Dedicated
27722 Durham, North Carolina
IQVIA
Posted 13 days ago
Job Viewed
Job Description
To be eligible for this position, you must reside in the same country where the job is located.
Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.
Award winning and innovative, we'll give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You'll be building a smart and flexible career with no limits.
**While projects vary, your typical responsibilities might include:**
+ Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.
You should have:
+ A Bachelor's degree in a health care or other scientific discipline or educational equivalent
+ Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience. 2 years of clinical research coordinator experience strongly preferred.
+ Alternatively, you should have an equivalent combination of education, training and experience
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
#CRASDAJD
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $64,000.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.
Award winning and innovative, we'll give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You'll be building a smart and flexible career with no limits.
**While projects vary, your typical responsibilities might include:**
+ Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.
You should have:
+ A Bachelor's degree in a health care or other scientific discipline or educational equivalent
+ Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience. 2 years of clinical research coordinator experience strongly preferred.
+ Alternatively, you should have an equivalent combination of education, training and experience
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
#CRASDAJD
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $64,000.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
View Now
3
Clinical Research Associate - Sponsor Dedicated
27722 Durham, North Carolina
IQVIA
Posted 13 days ago
Job Viewed
Job Description
Job Overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications:
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 1.5 years of year of on-site monitoring experience. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications:
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 1.5 years of year of on-site monitoring experience. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
View Now
4
Clinical Research Associate, Sponsor Dedicated
27722 Durham, North Carolina
IQVIA
Posted 13 days ago
Job Viewed
Job Description
To be eligible for this position, you must reside in the same country where the job is located.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
View Now
5
(Senior) Clinical Research Associate - Sponsor Dedicated
27722 Durham, North Carolina
IQVIA
Posted 13 days ago
Job Viewed
Job Description
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training visits.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 4 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Strong therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training visits.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 4 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Strong therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
View Now
Be The First To Know
About the latest Academic researchers Jobs in Raleigh !
6
Senior Associate Research Scientist
27709 Research Triangle Park, North Carolina
Grifols Shared Services North America, Inc
Posted 13 days ago
Job Viewed
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
This Senior Associate Research Scientist I position is in the CMC Product Development, Bioanalytics, Analytical Operations Group. The selected candidate will be responsible for conducting testing of process intermediates and final container in support of manufacturing, process development, developmental stability, validation and other R&D projects. Other responsibilities include cGXP documentation, sample login, data review, instrument maintenance and troubleshooting, data analysis, and other tasks assigned by management. The analyst may participate in development, execution, and qualification of new analytical test methods for characterization. The incumbent will be expected to work effectively under minimal supervision, and contribute to the team effort to support R&D projects.
**Note: This position is located in Research Triangle Park, NC**
**Job Responsibilities:**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
+ The candidate will independently perform technically diverse testing and analysis with minimal supervision/assistance using modern instrumental analytical techniques including but not limited to coagulation assays, enzymatic assays, immunoassays, chromatography, electrophoresis, UV-Vis spectrophotometry.
+ The candidate may assist in coordination of specific activities such as method development and method qualification.
+ The candidate may be responsible for authoring technical reports for development and regulatory submissioon.
+ Other duties as assigned by laboratory management.
**Minimum Qualifications:**
+ The candidate must have experience in the use of modern instrumental analytical techniques including but not limited to coagulation assays, enzymatic assays, and immunoassays, chromatography (UPLC, HPLC, GC, IC), Karl Fischer, capillary electrophoresis, and gel electrophoresis, sub-visible particulate analysis by light obscuration (SVP HIAC) or Micro-Flow Imagaing (MFI).
+ The candidate must be knowledgeable of cGXP requirements with respect to testing, documentation, and investigations, and data review.
+ The candidate must have strong scientific understanding of the test methods being performed, understanding of the products/intermediates being tested, the ability to recognize aberrant results and follow procedures for initiating investigations when necessary.
+ The candidate must have extensive technical problem-solving skills.
+ The candiate must have relevant experience with instrument qualification, method development, and method qualification for relevant assays and specific instrumentation such as immunonephelometry (BNII), coagulation analyzer (BCS-XP), enzymatic assays and ELISA (plate readers), electrophoresis (CZE, ProteinSimple Wes), chromatography (UPLC, HPLC, GC, IC), sub-visible particluates (SVP HIAC, MFI) etc.
+ Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Teams).
**Preferred Qualifications:**
+ The candidate must be results oriented, have a strong attention to detail and must be able to interpret data trends and troubleshoot methods and instrumentation.
+ The candidate must have the proven abilityies to recognize when to modify a standard approach to be more effective, make structured decisions on a routine basis and effectively prioritize and manage multiple tasks to meet targeted deadlines.
+ The candidate must have original thought, proven verbal and written communication skills, strong interpersonal skills, and the experience interacting with scientific and non-scientific personnel at all levels in a team environment.
+ Experience with software validation preferred.
**Senior Associate Research Scientist I:**
Degree must be within a relevant field: (Biology, Biochemistry, Chemistry, or Toxicology) Masters plus minimum 1 year of relevant experience, or Bachelors plus minimum 3-4 years of relevant experience, No degree requires minimum 7 years of relevant experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
**Occupational Demands:**
Work is performed in a laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.**
Learn more about Grifols ( ID:** 526530
**Type:** Regular Full-Time
**Job Category:** Research & Development
This Senior Associate Research Scientist I position is in the CMC Product Development, Bioanalytics, Analytical Operations Group. The selected candidate will be responsible for conducting testing of process intermediates and final container in support of manufacturing, process development, developmental stability, validation and other R&D projects. Other responsibilities include cGXP documentation, sample login, data review, instrument maintenance and troubleshooting, data analysis, and other tasks assigned by management. The analyst may participate in development, execution, and qualification of new analytical test methods for characterization. The incumbent will be expected to work effectively under minimal supervision, and contribute to the team effort to support R&D projects.
**Note: This position is located in Research Triangle Park, NC**
**Job Responsibilities:**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
+ The candidate will independently perform technically diverse testing and analysis with minimal supervision/assistance using modern instrumental analytical techniques including but not limited to coagulation assays, enzymatic assays, immunoassays, chromatography, electrophoresis, UV-Vis spectrophotometry.
+ The candidate may assist in coordination of specific activities such as method development and method qualification.
+ The candidate may be responsible for authoring technical reports for development and regulatory submissioon.
+ Other duties as assigned by laboratory management.
**Minimum Qualifications:**
+ The candidate must have experience in the use of modern instrumental analytical techniques including but not limited to coagulation assays, enzymatic assays, and immunoassays, chromatography (UPLC, HPLC, GC, IC), Karl Fischer, capillary electrophoresis, and gel electrophoresis, sub-visible particulate analysis by light obscuration (SVP HIAC) or Micro-Flow Imagaing (MFI).
+ The candidate must be knowledgeable of cGXP requirements with respect to testing, documentation, and investigations, and data review.
+ The candidate must have strong scientific understanding of the test methods being performed, understanding of the products/intermediates being tested, the ability to recognize aberrant results and follow procedures for initiating investigations when necessary.
+ The candidate must have extensive technical problem-solving skills.
+ The candiate must have relevant experience with instrument qualification, method development, and method qualification for relevant assays and specific instrumentation such as immunonephelometry (BNII), coagulation analyzer (BCS-XP), enzymatic assays and ELISA (plate readers), electrophoresis (CZE, ProteinSimple Wes), chromatography (UPLC, HPLC, GC, IC), sub-visible particluates (SVP HIAC, MFI) etc.
+ Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Teams).
**Preferred Qualifications:**
+ The candidate must be results oriented, have a strong attention to detail and must be able to interpret data trends and troubleshoot methods and instrumentation.
+ The candidate must have the proven abilityies to recognize when to modify a standard approach to be more effective, make structured decisions on a routine basis and effectively prioritize and manage multiple tasks to meet targeted deadlines.
+ The candidate must have original thought, proven verbal and written communication skills, strong interpersonal skills, and the experience interacting with scientific and non-scientific personnel at all levels in a team environment.
+ Experience with software validation preferred.
**Senior Associate Research Scientist I:**
Degree must be within a relevant field: (Biology, Biochemistry, Chemistry, or Toxicology) Masters plus minimum 1 year of relevant experience, or Bachelors plus minimum 3-4 years of relevant experience, No degree requires minimum 7 years of relevant experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
**Occupational Demands:**
Work is performed in a laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.**
Learn more about Grifols ( ID:** 526530
**Type:** Regular Full-Time
**Job Category:** Research & Development
View Now
7
Clinical Research Associate - Northeast or Central Region - FSP
27722 Durham, North Carolina
Parexel
Posted 2 days ago
Job Viewed
Job Description
The Clinical Research Associate/Site Monitor will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).
+ Ensuring regulatory, ICH-GCP and protocol compliance.
+ Uses judgement and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
+ Maintains a working knowledge of ICH-GCP guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
+ Immediately communicates and escalates significant issues to the project team and develops action plans
+ Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required
+ Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues
+ Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
+ Conducts source document review and verification of appropriate site source documents and medical records
+ Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
+ Manages reporting of protocol deviations and appropriate follow up
+ Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
+ Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
+ May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security
+ Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP
+ Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released and returned
+ Manages reporting of identified issues and manages follow up to resolution
+ Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
+ Ensures all activities are managed by site personnel who are appropriately delegated and trained
+ Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
+ For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets
+ Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks
+ Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
+ Conducts follow up for escalated adverse event monitoring (AEM) report query
+ Checks the site and external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
+ Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log)
**Knowledge and Experience** :
+ A minimum of 1 year of experience as a clinical monitor with demonstrated experience of monitoring
+ Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence)
+ Experience monitoring vaccines trials
**Education:**
+ Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
#LI-LO1
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
+ Ensuring regulatory, ICH-GCP and protocol compliance.
+ Uses judgement and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
+ Maintains a working knowledge of ICH-GCP guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
+ Immediately communicates and escalates significant issues to the project team and develops action plans
+ Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required
+ Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues
+ Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
+ Conducts source document review and verification of appropriate site source documents and medical records
+ Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
+ Manages reporting of protocol deviations and appropriate follow up
+ Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
+ Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
+ May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security
+ Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP
+ Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released and returned
+ Manages reporting of identified issues and manages follow up to resolution
+ Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
+ Ensures all activities are managed by site personnel who are appropriately delegated and trained
+ Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
+ For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets
+ Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks
+ Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
+ Conducts follow up for escalated adverse event monitoring (AEM) report query
+ Checks the site and external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
+ Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log)
**Knowledge and Experience** :
+ A minimum of 1 year of experience as a clinical monitor with demonstrated experience of monitoring
+ Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence)
+ Experience monitoring vaccines trials
**Education:**
+ Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
#LI-LO1
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
View Now
8
Clinical Research Associate II/Site Monitor II - Vaccines - FSP
27722 Durham, North Carolina
Parexel
Posted 5 days ago
Job Viewed
Job Description
The Clinical Research Associate II/Site Monitor II will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor II will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).
+ Ensuring regulatory, ICH-GCP and protocol compliance.
+ Uses judgement and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
+ Maintains a working knowledge of ICH-GCP guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
+ Immediately communicates and escalates significant issues to the project team and develops action plans
+ Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required
+ Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues
+ Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
+ Conducts source document review and verification of appropriate site source documents and medical records
+ Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
+ Manages reporting of protocol deviations and appropriate follow up
+ Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
+ Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
+ May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security
+ Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP
+ Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released and returned
+ Manages reporting of identified issues and manages follow up to resolution
+ Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
+ Ensures all activities are managed by site personnel who are appropriately delegated and trained
+ Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
+ For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets
+ Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks
+ Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
+ Conducts follow up for escalated adverse event monitoring (AEM) report query
+ Checks the site and external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
+ Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log)
**Knowledge and Experience** :
+ A minimum of 3 years experience as a clinical monitor with demonstrated experience of monitoring
+ Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence)
+ Experience monitoring vaccines trials
**Education:**
+ Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
#LI-LG4
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
+ Ensuring regulatory, ICH-GCP and protocol compliance.
+ Uses judgement and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
+ Maintains a working knowledge of ICH-GCP guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
+ Immediately communicates and escalates significant issues to the project team and develops action plans
+ Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required
+ Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues
+ Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
+ Conducts source document review and verification of appropriate site source documents and medical records
+ Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
+ Manages reporting of protocol deviations and appropriate follow up
+ Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
+ Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
+ May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security
+ Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP
+ Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released and returned
+ Manages reporting of identified issues and manages follow up to resolution
+ Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
+ Ensures all activities are managed by site personnel who are appropriately delegated and trained
+ Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
+ For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets
+ Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks
+ Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
+ Conducts follow up for escalated adverse event monitoring (AEM) report query
+ Checks the site and external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
+ Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log)
**Knowledge and Experience** :
+ A minimum of 3 years experience as a clinical monitor with demonstrated experience of monitoring
+ Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence)
+ Experience monitoring vaccines trials
**Education:**
+ Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
#LI-LG4
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
View Now
9