Explore exciting opportunities as a Senior Clinical Research Associate (SCRA) in the United States. This pivotal role involves overseeing clinical trials, managing data, and ensuring compliance with regulatory standards. SCRAs are vital in advancing medical research and bringing new treatments to market. If you have a background in life sciences and experience in clinical trial management, this could be your next career step.What Senior Clinical Research Associate Jobs are in the United States?
Showing 5000+ Senior Clinical Research Associate jobs in the United States
Clinical Research Associate/Senior Clinical Research Associate- FSP
Posted 8 days ago
Job Viewed
Job Description
**Parexel FSP is looking for a CRA/Sr CRA in the US.** **Oncology Experience required. Cell therapy experience is strongly preferred.**
**Job Purpose:**
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
**EEO Disclaimer**
**Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.**
\#LI-KW1
\#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.
**Job Purpose:**
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
**EEO Disclaimer**
**Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.**
\#LI-KW1
\#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.
Is this job a match or a miss?
Apply Now
0
Clinical Research Associate
Posted 1 day ago
Job Viewed
Job Description
Job Title: Clinical Research Associate
Job Description
We are seeking committed, skilled, and customer-focused individuals to join our growing team as an experienced Clinical Research Associate (CRA). This is a full-time position for candidates with at least one year of monitoring experience in the clinical research field.
Responsibilities
+ Identify and select study sites for clinical trials.
+ Perform regulatory and ethics committee submissions.
+ Monitor clinical studies to ensure compliance with protocols.
+ Manage site activities and local safety reporting as needed.
Essential Skills
+ At least one year of clinical trials monitoring experience.
+ University degree in life science.
+ Excellent written and oral communication skills.
+ Attention to detail.
+ Good organizational and time management skills.
+ Fluent in written and verbal English.
+ Ability to work well within a team.
+ Computer competency.
+ Position requires up to 50%-60% travel.
Additional Skills & Qualifications
+ Experience in clinical research, clinical trials, pain management, and oncology.
+ Experience in CRO, Pharma, and Clinical Monitoring.
Work Environment
The position offers remote work opportunities with occasional onsite visits. The role requires a significant amount of travel, up to 50%-60%, allowing for flexibility and autonomy in managing work schedules
Job Type & Location
This is a Contract position based out of Phoenix, AZ.
Pay and Benefits
The pay range for this position is $85.00 - $95.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Jul 24, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Job Description
We are seeking committed, skilled, and customer-focused individuals to join our growing team as an experienced Clinical Research Associate (CRA). This is a full-time position for candidates with at least one year of monitoring experience in the clinical research field.
Responsibilities
+ Identify and select study sites for clinical trials.
+ Perform regulatory and ethics committee submissions.
+ Monitor clinical studies to ensure compliance with protocols.
+ Manage site activities and local safety reporting as needed.
Essential Skills
+ At least one year of clinical trials monitoring experience.
+ University degree in life science.
+ Excellent written and oral communication skills.
+ Attention to detail.
+ Good organizational and time management skills.
+ Fluent in written and verbal English.
+ Ability to work well within a team.
+ Computer competency.
+ Position requires up to 50%-60% travel.
Additional Skills & Qualifications
+ Experience in clinical research, clinical trials, pain management, and oncology.
+ Experience in CRO, Pharma, and Clinical Monitoring.
Work Environment
The position offers remote work opportunities with occasional onsite visits. The role requires a significant amount of travel, up to 50%-60%, allowing for flexibility and autonomy in managing work schedules
Job Type & Location
This is a Contract position based out of Phoenix, AZ.
Pay and Benefits
The pay range for this position is $85.00 - $95.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Jul 24, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Is this job a match or a miss?
Apply Now
1
Clinical Research Associate I
Posted today
Job Viewed
Job Description
Clinical Research Associate I
**Required Qualifications** **(as evidenced by an attached resume):**
Bachelor's Degree (foreign equivalent or higher) and two (2) years of full-time related research experience in clinical trials research, research database management, and working with Institutional Review Board. In lieu of a bachelor's degree and two (2) years of full-time related research experience, a medical degree (MD, DO, MBBS or equivalent) may be considered. Completion of an Internal Medicine Residency Training program. Successful Completion of all three United States Medical Licensing Examination (USMLE exams). Proficiency with MS Word and Excel.
**Preferred Qualifications:**
Experience with scanning procedures. Experience with testing. Experience with data processing. Experience working with an electronic database. Experience working with study participants.
**Brief Description of Duties:**
The Clinical Research Associate will assist with research studies. They may interact directly with study participants. The incumbent will coordinate scheduled visits with other research team members. They will also assist with maintaining the integrity of collected data in an electronic database and assist with maintaining the study protocol documents and compliance with all Institutional Review Board policies. The successful incumbent must have excellent interpersonal, organizational and time-management skills.
**Duties:**
+ Coordinate various research trials and ensure compliance with federal guidelines.
+ Interact and correspond with various internal and external constituents including sponsors, cooperative groups, Institutional Review Board and regulatory agencies.
+ Enroll, register and screen patients for clinical research trials; collect and submit clinical trial Patient data.
+ Perform various administrative duties, which may include proper collection and shipment of lab samples; billing, budgeting and contract administration; maintenance of clinical research study supplies and drug accountability.
+ May assist principal investigator with grant submissions and renewals. Depending on the nature of protocol, some positions may perform patient care duties related to protocol.
+ Other duties as assigned
**Special Notes:**
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
**For this position, we are unable to sponsor candidates for work visas.**
Resume/CV and cover letter should be included with the online application.
**_Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws._**
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at or visit OEA ( .
_In accordance with the Title II Crime Awareness and Security Act_ a _copy of our crime statistics can be viewed_ here ( _._
Visit our WHY WORK HERE ( page to learn about the **total rewards** we offer.
**The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.**
**_\#LI-SA1_**
**Job Number:**
**Official Job Title:** : Clinical Research Associate I
**Job Field** : Research Professional / Technical
**Primary Location** : US-NY-Stony Brook
**Department/Hiring Area:** : Medicine / Nephrology
**Schedule** : Full-time
**Shift** : Day Shift **Shift Hours:** : 8:30am - 5:00pm :
**Posting Start Date** : Jul 7, 2026
**Posting End Date** : Aug 4, 2026, 10:59:00 PM
**Salary:** : $60,000-$70,000
**Appointment Type:** : Regular
**Salary Grade:** : E99
**SBU Area:** : The Research Foundation for The State University of New York at Stony Brook
**Req ID:**
**Required Qualifications** **(as evidenced by an attached resume):**
Bachelor's Degree (foreign equivalent or higher) and two (2) years of full-time related research experience in clinical trials research, research database management, and working with Institutional Review Board. In lieu of a bachelor's degree and two (2) years of full-time related research experience, a medical degree (MD, DO, MBBS or equivalent) may be considered. Completion of an Internal Medicine Residency Training program. Successful Completion of all three United States Medical Licensing Examination (USMLE exams). Proficiency with MS Word and Excel.
**Preferred Qualifications:**
Experience with scanning procedures. Experience with testing. Experience with data processing. Experience working with an electronic database. Experience working with study participants.
**Brief Description of Duties:**
The Clinical Research Associate will assist with research studies. They may interact directly with study participants. The incumbent will coordinate scheduled visits with other research team members. They will also assist with maintaining the integrity of collected data in an electronic database and assist with maintaining the study protocol documents and compliance with all Institutional Review Board policies. The successful incumbent must have excellent interpersonal, organizational and time-management skills.
**Duties:**
+ Coordinate various research trials and ensure compliance with federal guidelines.
+ Interact and correspond with various internal and external constituents including sponsors, cooperative groups, Institutional Review Board and regulatory agencies.
+ Enroll, register and screen patients for clinical research trials; collect and submit clinical trial Patient data.
+ Perform various administrative duties, which may include proper collection and shipment of lab samples; billing, budgeting and contract administration; maintenance of clinical research study supplies and drug accountability.
+ May assist principal investigator with grant submissions and renewals. Depending on the nature of protocol, some positions may perform patient care duties related to protocol.
+ Other duties as assigned
**Special Notes:**
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
**For this position, we are unable to sponsor candidates for work visas.**
Resume/CV and cover letter should be included with the online application.
**_Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws._**
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at or visit OEA ( .
_In accordance with the Title II Crime Awareness and Security Act_ a _copy of our crime statistics can be viewed_ here ( _._
Visit our WHY WORK HERE ( page to learn about the **total rewards** we offer.
**The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.**
**_\#LI-SA1_**
**Job Number:**
**Official Job Title:** : Clinical Research Associate I
**Job Field** : Research Professional / Technical
**Primary Location** : US-NY-Stony Brook
**Department/Hiring Area:** : Medicine / Nephrology
**Schedule** : Full-time
**Shift** : Day Shift **Shift Hours:** : 8:30am - 5:00pm :
**Posting Start Date** : Jul 7, 2026
**Posting End Date** : Aug 4, 2026, 10:59:00 PM
**Salary:** : $60,000-$70,000
**Appointment Type:** : Regular
**Salary Grade:** : E99
**SBU Area:** : The Research Foundation for The State University of New York at Stony Brook
**Req ID:**
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2
Clinical Research Associate 2
Posted today
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.
**The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.**
**Primary responsibilities include:**
+ **Tracking study specific tasks and progress of the trial.**
+ **Performing regulatory document review and approval for IP release.**
+ **Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).**
+ **Conducting monitor training.**
+ **Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.**
+ **Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.**
+ **Collaborating with data management to resolve queries.**
+ **Facilitating investigator site payments, as applicable.**
+ **Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.**
+ **Assisting in evaluation of vendor performance during conduct of the study.**
+ **Acquiring a basic knowledge of the therapeutic area and product.**
+ **Obtaining a complete understanding of all trial-related documents and operational procedures.**
+ **Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes.**
+ **Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable**
+ **Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).**
+ **Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.**
+ **Preparing accurate and complete meeting minutes for various meetings.**
+ **Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.**
+ **Assists with effective and timely audit/inspection responses.**
**For studies monitored in house by Grifols, additional responsibilities may include:**
+ Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
+ Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
+ Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance.
+ Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Reconciles clinical supplies and drug accountability records at study sites.
+ Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
+ Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
+ Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.
**Additional responsibilities:**
Assists in the development of study timelines and ensures compliance. Assists in the management of vendors. Prepares key reports and documents on progress of study for study manager. Monitors adherence to the regulatory document collection process. Interacts with data management, safety, regulatory personnel, and other functional groups. Assists team members in reviewing data listings and writing queries. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Reviews study specific ICF(s) for compliance with ICH/GCP and company SOPs. Participates in CRF development and completion.
**Knowledge, Skills, and Abilities:**
Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Good knowledge of therapeutic area assigned. Strong knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel.
**Requirements:**
+ Associate's degree in a life science field required. Bachelor's degree in a life science field preferred.
+ Typically requires 2 years of experience in clinical research, including a minimum of 1 year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
+ 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. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
**Occupational Demands:**
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** R & D
**The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.**
**Primary responsibilities include:**
+ **Tracking study specific tasks and progress of the trial.**
+ **Performing regulatory document review and approval for IP release.**
+ **Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).**
+ **Conducting monitor training.**
+ **Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.**
+ **Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.**
+ **Collaborating with data management to resolve queries.**
+ **Facilitating investigator site payments, as applicable.**
+ **Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.**
+ **Assisting in evaluation of vendor performance during conduct of the study.**
+ **Acquiring a basic knowledge of the therapeutic area and product.**
+ **Obtaining a complete understanding of all trial-related documents and operational procedures.**
+ **Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes.**
+ **Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable**
+ **Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).**
+ **Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.**
+ **Preparing accurate and complete meeting minutes for various meetings.**
+ **Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.**
+ **Assists with effective and timely audit/inspection responses.**
**For studies monitored in house by Grifols, additional responsibilities may include:**
+ Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
+ Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
+ Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance.
+ Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Reconciles clinical supplies and drug accountability records at study sites.
+ Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
+ Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
+ Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.
**Additional responsibilities:**
Assists in the development of study timelines and ensures compliance. Assists in the management of vendors. Prepares key reports and documents on progress of study for study manager. Monitors adherence to the regulatory document collection process. Interacts with data management, safety, regulatory personnel, and other functional groups. Assists team members in reviewing data listings and writing queries. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Reviews study specific ICF(s) for compliance with ICH/GCP and company SOPs. Participates in CRF development and completion.
**Knowledge, Skills, and Abilities:**
Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Good knowledge of therapeutic area assigned. Strong knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel.
**Requirements:**
+ Associate's degree in a life science field required. Bachelor's degree in a life science field preferred.
+ Typically requires 2 years of experience in clinical research, including a minimum of 1 year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
+ 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. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
**Occupational Demands:**
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** R & D
Is this job a match or a miss?
Apply Now
3
Senior Clinical Research Associate
Posted 13 days ago
Job Viewed
Job Description
Senior Clinical Research Associate - Oncology - West Region
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**What You Will Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**You are:**
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Eligible to work in United States without visa sponsorship
+ A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Experienced monitoring Oncology (i.e. Prostate Cancer, and Lung Cancer) and/or Hematology Oncology trials.
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel up to 50% for on-site monitoring visits across the West region; preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Salary range: $110,520.00-$138,150.00
Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
**What You Will Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**You are:**
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Eligible to work in United States without visa sponsorship
+ A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Experienced monitoring Oncology (i.e. Prostate Cancer, and Lung Cancer) and/or Hematology Oncology trials.
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel up to 50% for on-site monitoring visits across the West region; preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Salary range: $110,520.00-$138,150.00
Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.
Are you a current ICON Employee? Please click here ( to apply
Is this job a match or a miss?
Apply Now
4
Senior Clinical Research Associate/Clinical Research Associate - All US Locations - FSP
Posted 8 days ago
Job Viewed
Job Description
**Job Purpose:**
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
\#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.
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
\#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.
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5
Senior Clinical Research Associate - Texas - FSP
Posted 6 days ago
Job Viewed
Job Description
The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
\#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.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
\#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.
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6
Clinical Research Associate I
Posted 2 days ago
Job Viewed
Job Description
**Associate Scientist - Genomic Medicine**
**Waltham, MA**
**Pay Rate:** **$** **36.29/hour**
**Schedule:** Monday-Friday, 1st Shift
**Position Type:** Contract
**Position Summary**
We are seeking a motivated and detail-oriented **Associate Scientist** to join a Genomic Medicine team focused on developing innovative gene therapies for neuromuscular disorders. This role will support research initiatives through hands-on laboratory work, with an emphasis on molecular and cellular biology techniques, in vivo studies, experimental execution, and data analysis.
The successful candidate will collaborate closely with scientists across teams and contribute to advancing research programs through rigorous scientific practices, strong documentation, and effective communication.
**Key Responsibilities**
+ Independently perform laboratory experiments and analyze data to support research program goals.
+ Develop and execute cell-based screening assays for novel compounds.
+ Support in vivo studies, including animal handling, injections, and tissue collection.
+ Perform molecular and cellular biology techniques to support research activities.
+ Maintain accurate documentation and ensure compliance with company quality standards.
+ Utilize electronic laboratory notebooks (ELN) to record experimental procedures and results.
+ Collaborate effectively with internal team members and cross-functional partners.
+ Present findings and communicate research updates clearly to project teams.
+ Promote a culture of teamwork, collaboration, and scientific excellence.
**Required Qualifications**
+ Bachelor's degree (BA/BS) in Life Sciences or a related scientific field.
+ 2-4 years of experience as an Associate Scientist or similar role in an academic, biotechnology, or biopharmaceutical laboratory setting.
+ Strong molecular biology experience, including:
+ RNA/DNA isolation
+ qPCR and digital PCR assays
+ ELISA
+ Imaging techniques
+ Experience with mammalian cell culture, including:
+ Cell maintenance
+ Nucleic acid transfection
+ Experience with animal handling, including mice injections and tissue collection.
+ Strong organizational skills and attention to detail.
+ Ability to effectively communicate scientific findings and document research activities.
**Preferred Qualifications**
+ Experience working in gene therapy, genomic medicine, or related research areas.
+ Strong problem-solving skills and ability to work independently.
+ Excellent teamwork and collaboration skills in a research environment.
**Schedule & Additional Information**
+ **Location:** Waltham, MA
+ **Shift:** Monday-Friday, 1st Shift
+ **Work Setting:** Laboratory/Research Environment
+ **Assessment Requirements:** None
+ **Education Requirement:** Bachelor's degree in Life Sciences or related field with 2-4 years of relevant laboratory experience.
**Pay Details:** $36.29 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
+ The California Fair Chance Act
+ Los Angeles City Fair Chance Ordinance
+ Los Angeles County Fair Chance Ordinance for Employers
+ San Francisco Fair Chance Ordinance
**Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Waltham, MA**
**Pay Rate:** **$** **36.29/hour**
**Schedule:** Monday-Friday, 1st Shift
**Position Type:** Contract
**Position Summary**
We are seeking a motivated and detail-oriented **Associate Scientist** to join a Genomic Medicine team focused on developing innovative gene therapies for neuromuscular disorders. This role will support research initiatives through hands-on laboratory work, with an emphasis on molecular and cellular biology techniques, in vivo studies, experimental execution, and data analysis.
The successful candidate will collaborate closely with scientists across teams and contribute to advancing research programs through rigorous scientific practices, strong documentation, and effective communication.
**Key Responsibilities**
+ Independently perform laboratory experiments and analyze data to support research program goals.
+ Develop and execute cell-based screening assays for novel compounds.
+ Support in vivo studies, including animal handling, injections, and tissue collection.
+ Perform molecular and cellular biology techniques to support research activities.
+ Maintain accurate documentation and ensure compliance with company quality standards.
+ Utilize electronic laboratory notebooks (ELN) to record experimental procedures and results.
+ Collaborate effectively with internal team members and cross-functional partners.
+ Present findings and communicate research updates clearly to project teams.
+ Promote a culture of teamwork, collaboration, and scientific excellence.
**Required Qualifications**
+ Bachelor's degree (BA/BS) in Life Sciences or a related scientific field.
+ 2-4 years of experience as an Associate Scientist or similar role in an academic, biotechnology, or biopharmaceutical laboratory setting.
+ Strong molecular biology experience, including:
+ RNA/DNA isolation
+ qPCR and digital PCR assays
+ ELISA
+ Imaging techniques
+ Experience with mammalian cell culture, including:
+ Cell maintenance
+ Nucleic acid transfection
+ Experience with animal handling, including mice injections and tissue collection.
+ Strong organizational skills and attention to detail.
+ Ability to effectively communicate scientific findings and document research activities.
**Preferred Qualifications**
+ Experience working in gene therapy, genomic medicine, or related research areas.
+ Strong problem-solving skills and ability to work independently.
+ Excellent teamwork and collaboration skills in a research environment.
**Schedule & Additional Information**
+ **Location:** Waltham, MA
+ **Shift:** Monday-Friday, 1st Shift
+ **Work Setting:** Laboratory/Research Environment
+ **Assessment Requirements:** None
+ **Education Requirement:** Bachelor's degree in Life Sciences or related field with 2-4 years of relevant laboratory experience.
**Pay Details:** $36.29 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
+ The California Fair Chance Act
+ Los Angeles City Fair Chance Ordinance
+ Los Angeles County Fair Chance Ordinance for Employers
+ San Francisco Fair Chance Ordinance
**Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Is this job a match or a miss?
Apply Now
7
Senior Clinical Research Associate
Posted 21 days ago
Job Viewed
Job Description
**General Description:**
The SCRA is primarily a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical study activities, departmental tasks, and provides mentoring to other CRA team members within established protocols and portfolio under general supervision.
Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management group as well as within the greater Americas region.
**Essential Functions of the job:**
- Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
- Develop collaborative relationships with investigative sites, and study vendors
- Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
- Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status are kept current by the monitoring team
- Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
- Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed
- Perform study-specific training with project team
- Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
- Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies
- Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines
- Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites within established protocols and portfolio under general supervision
- Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
- Provide support for study sites, and CRAs with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff.
- Assist with other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff.
**Supervisory Responsibilities:**
- Provides site level management for established protocols and portfolio under general supervision
- Provides mentoring/support to CRAs for study related topics
- Identification of development opportunities and provides necessary training to for junior team members as needed
- Co-monitoring with CRAs and support site visits, as needed
**Computer Skills:**
- Efficient in Microsoft Word, Excel, PowerPoint and Outlook
- Familiar with industry CTMS and data management systems
**Other Qualifications:**
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- Minimum of 4-6 years of relevant Clinical Operations experience
- Minimum of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
Travel: up to 40 -60% time
**Education Required:**
BS/BA in a relevant scientific discipline and minimum of 4-6 years of relevant Clinical Operations experience, and minimum of 3-4 years of monitoring experience. Experience in global oncology trials preferred.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
The SCRA is primarily a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical study activities, departmental tasks, and provides mentoring to other CRA team members within established protocols and portfolio under general supervision.
Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management group as well as within the greater Americas region.
**Essential Functions of the job:**
- Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
- Develop collaborative relationships with investigative sites, and study vendors
- Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
- Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status are kept current by the monitoring team
- Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
- Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed
- Perform study-specific training with project team
- Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
- Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies
- Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines
- Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites within established protocols and portfolio under general supervision
- Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
- Provide support for study sites, and CRAs with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff.
- Assist with other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff.
**Supervisory Responsibilities:**
- Provides site level management for established protocols and portfolio under general supervision
- Provides mentoring/support to CRAs for study related topics
- Identification of development opportunities and provides necessary training to for junior team members as needed
- Co-monitoring with CRAs and support site visits, as needed
**Computer Skills:**
- Efficient in Microsoft Word, Excel, PowerPoint and Outlook
- Familiar with industry CTMS and data management systems
**Other Qualifications:**
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- Minimum of 4-6 years of relevant Clinical Operations experience
- Minimum of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
Travel: up to 40 -60% time
**Education Required:**
BS/BA in a relevant scientific discipline and minimum of 4-6 years of relevant Clinical Operations experience, and minimum of 3-4 years of monitoring experience. Experience in global oncology trials preferred.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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8