3,049 Parexel jobs in the United States
Clinical Trials Coordinator
Posted 4 days ago
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Job DetailsJob LocationPhoenix-7th - Phoenix, AZPosition TypeFull TimeSalary Range$ - $ Salary/yearJob Posting Date(s)Start Date08/28/2025DescriptionSECTION 1: Job Summary (Summary of the basic functions of the position)Under general supervision of a physician in an outpatient clinical setting, provides assistance to principalinvestigator to complete clinical trial visits. Ensures that trial subjects are scheduled appropriately and allprotocol-specified tasks are performed in a timely manner.SECTION 2: Duties and Responsibilities (Responsibilities necessary to accomplish job functions)Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visitsConduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visitsEducate patients on study-specific protocol requirements, procedures, side effects and risks of trials and investigative medicationsCommunicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day to day needs for current and prospective trialsMaintain all source documents and investigational drug accountability recordsEnter source data into EDC within one calendar day of subject visitContinually review EDC for accuracy and completion, and resolve queries as they ariseAssists with direct patient care procedures including biopsies, surgeries, cosmetic procedures and related tasks; records patient medical history and exam notes in EMR. Selects appropriate billing and diagnosis codes based on procedures performedProcess prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programsScans correspondence into EMRStocks and organizes medical supplies in exam rooms as needed. Notify appropriate personnel when supplies are neededPractices safety, environmental, and/or infection control methodsPerforms miscellaneous job-related duties as assignedProcess blood and urine samples in accordance with IATA and OSHA standardsWorking knowledge, at minimum, of all applicable protocols. Some team members may be assigned as the primary coordinator for a specific protocol, and should therefore have in-depth knowledge of that protocol.QualificationsSECTION 3: Experience Requirements4 years / Bachelor's Degree, or:Medical assistant or equivalent clinical training; at least 1 year of experience that is directly related to the duties and responsibilities specified.SECTION 4: Knowledge, Skills and Abilities RequirementsMeticulously detail oriented, professional attitude, reliableOrganizational skills to support accurate record-keepingAbility to follow verbal & written instructionsInterpersonal skills to work as a team with patients and outside partiesAble to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretationsMathematical and analytical ability for basic to intermediate problem solvingBasic to intermediate computer operationProficiency with Microsoft Excel, Word, and OutlookSpecialty knowledge of systems relating to job functionKnowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelinesSECTION 5: Supervisory Responsibilities:This position has no supervisory responsibilities.Benefits:Medical,Dental,&Vision401kPTO&PaidHolidaysCompanyPaidLifeInsuranceEmployeePerksProgram
Clinical Trials Manager
Posted 4 days ago
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Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Job Description
CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.
Key Responsibilities:
- In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
- Communicates with functional peers regarding project status and issues and ensure project team goals are met
- Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
- Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
- Coordinates data review to support interim/final data analysis
- Participates in study strategy development.
- Maintains study timelines.
- Contributes to development of study budget.
- Contributes to development of RFPs and participate in selection of CROs/vendors.
- Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
- May participates in the recruiting and hiring process for CTMs and supports their professional development
- May mentor other junior team members
- Coaches members of a work team and ensures adherence to established guidelines
- BS/BA degree in nursing, science or health related field with at least 5 years of trial management experience - OR -
- MS/MA degree in nursing, science or health related field with at least 3 years of trial management experience
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
- Highly developed leadership skills to successfully lead a clinical study team
- Ability to deal with time demands, incomplete information or unexpected events
- Must display strong analytical and problem solving skills
- Attention to detail
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
- Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
- Familiar with standard medical / scientific terminology.
- Ability to communicate in a clear and concise manner.
- Ability to support a team-oriented, highly-matrixed environment.
- Ability to execute multiple tasks as assigned.
- When needed, ability to travel.
The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Clinical Trials Manager
Posted 4 days ago
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Job Description
The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland .
*This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.*
DESCRIPTION OF RESPONSIBILITIES:
- Reports directly to the Program Manager.
- Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
- Defines the trial budget and schedule.
- Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
- Oversees the screening and qualification of potential study subjects.
- Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
- Monitors progress of the trial and reports any issues to the trial director or physician.
- Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
- Reviews and updates all Standard Operating Procedures (SOPs) as required.
- Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
- Provides and/or coordinates all contractually required reports.
- May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
- Other duties as assigned by Supervisor.
REQUIRED DEGREE/EDUCATION/CERTIFICATION:
- Registered Nurse with five (5) years of experience in Clinical Research.
- Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
- Basic Life Support (BLS -CPR/ AED) certification.
REQUIRED SKILLS AND EXPERIENCE:
- Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
- Must be able to work independently following a brief period of specific technical training.
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
- Knowledge of applicable highly complex scientific procedures and techniques relating to position.
DESIRED SKILLS AND EXPERIENCE:
Advanced Cardiac Life Support (ACLS) certification encouraged.
REQUIRED CITIZENSHIP AND CLEARANCE:
- Must be a U.S. Citizen
- Must be able to pass a background check for a NACI.
The Alaka`na Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees
"EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans"
The Alaka ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.
For additional information, please visit
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#J-18808-LjbffrClinical Trials Intern

Posted today
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Job Description
**Job Summary:**
Interacts and participates with various divisions within Walgreens to assist in influencing key business decisions. Assists with and completes projects that contribute to the strategic initiatives and department goals of the function the role supports.
**Job Responsibilities:**
+ Performs various activities that contribute to the strategy development process for the assigned business unit.
+ Utilizes various tools and resources to analyze information and make recommendations to support the business.
+ Provides general day to day support across the various divisions within Walgreens.
+ Suggests recommendations to leadership for improving and updating policies and processes.
+ May deliver a project aligning to strategic priorities and present to manager/leadership upon completion.
**About Walgreens**
Founded in 1901, Walgreens ( proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for pharmacy, retail and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
**Job ID:** BR
**Title:** Clinical Trials Intern
**Company Indicator:** Walgreens
**Employment Type:**
**Job Function:** Business Development/Planning
**Full Store Address:** 108 WILMOT RD,DEERFIELD,IL 60015
**Full District Office Address:** 108 WILMOT RD,DEERFIELD,IL, -2
**External Basic Qualifications:**
+ Currently enrolled in a Bachelor's degree program with 2 semesters remaining upon start date
+ Experience communicating via written reports and presenting the information in a formal or classroom setting.
+ Experience collaborating with teams
+ Basic level skill in Microsoft Office Suite (Microsoft Word, PowerPoint, Excel).
**Preferred Qualifications:**
+ Pharm/Biology/Nursing experience
+ Phlebotomy experience
**Shift:**
**Store:**
**Pay Type:**
**Start Rate:**
**Max Rate:**
Clinical Trials Manager

Posted 2 days ago
Job Viewed
Job Description
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Job Description
**CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.
**Key Responsibilities:**
+ In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
+ Communicates with functional peers regarding project status and issues and ensure project team goals are met
+ Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
+ Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
+ Coordinates data review to support interim/final data analysis
+ Participates in study strategy development.
+ Maintains study timelines.
+ Contributes to development of study budget.
+ Contributes to development of RFPs and participate in selection of CROs/vendors.
+ Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
+ Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
+ Proactively identifies potential study issues/risks and recommends/implements solutions.
+ Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
+ May participates in the recruiting and hiring process for CTMs and supports their professional development
+ May mentor other junior team members
+ Coaches members of a work team and ensures adherence to established guidelines
**Basic Qualifications**
+ BS/BA degree in nursing, science or health related field with at least 5 years of trial management experience - OR -
+ MS/MA degree in nursing, science or health related field with at least 3 years of trial management experience
**Preferred Qualifications**
+ Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
+ Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
+ Highly developed leadership skills to successfully lead a clinical study team
+ Ability to deal with time demands, incomplete information or unexpected events
+ Must display strong analytical and problem solving skills
+ Attention to detail
+ Outstanding organizational skills with the ability to multi-task and prioritize
+ Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
+ Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
+ Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
+ Familiar with standard medical / scientific terminology.
+ Ability to communicate in a clear and concise manner.
+ Ability to support a team-oriented, highly-matrixed environment.
+ Ability to execute multiple tasks as assigned.
+ When needed, ability to travel.
The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Biostatistician - Clinical Trials
Posted 3 days ago
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Job Description
Clinical Trials - Clinical Data Associate
Posted 2 days ago
Job Viewed
Job Description
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.
***Please note, this is a hybrid position 3 days onsite/2 days remote***
**Purpose:**
This role is responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards. This role will collaborate with key study partners to define, implement, and deliver clinical data management packages. This role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs.
**Primary Responsibilities:**
**Portfolio Strategy, Planning and Delivery**
+ Define Lilly business requirements for the study/program for vendors to deliver
+ Ensure that data management timeline and results are delivered to scope, cost, and time objectives
+ Perform project monitoring and quality oversight of sourcing providers for end-to-end data management activities - from study set up through trial execution through dataset delivery
+ Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
+ Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis
+ Approve key outputs and results (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets)
+ Define and approve data quality and submission outputs and results
**Project Management**
+ Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
+ Specifies the data collection tools and technology platforms for the trial/program
+ Drive standards decisions, implementation and compliance for the study/program
+ Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios
+ Facilitate/assimilate integration of disparate data sources into datasets for decision making
+ Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
+ Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
**Communication**
+ Act as primary communication point for all data management activities related to a clinical study.
+ Report out status of data management milestones and data quality.
+ Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database.
+ Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence stakeholders to drive data-driven decisions.
+ Partner with cross-functional team members to ensure trial success through robust oversight/review.
**Process Improvement**
+ Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
+ Represent data sciences' processes in multi-functional initiatives.
+ Actively engage in shared learning across the Data and Analytics organization.
+ Work with partners to increase vendor/partner efficiencies
**Minimum Qualification Requirements:**
+ Master's degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences (or Bachelor's degree plus 3 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc.)
**Other** **Information/Additional** **Preferences:**
+ Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities
+ Demonstrated ability to effectively partner/influence a remote team and drive a technical project to deliver results
+ Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles
+ Demonstrated ability to lead development of creative data solutions to address clinical development challenges
+ Passionate about improving technological solutions using new technologies
+ Society of Clinical Data Management certification
+ Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, 'R' and Shiny for reporting, metrics and visualizations along with P-SQL, T-SQL for DBMS.
+ Experience with the following:
+ Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
+ Utilization of clinical/drug development knowledge and an ability to collaborate closely effectively with study team members (i.e. Statistics, PK, Operations, Medical)
+ Strong therapeutic/scientific knowledge in the field of research
+ Knowledge of medical terminology
+ Domestic and International travel may be required
+ Ability to balance multiple activities, prioritize and manage ambiguity
+ Demonstrated exemplary teamwork/interpersonal skills
+ Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $140,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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Clinical Research Coordinator - Clinical Trials
Posted 2 days ago
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MED-ZSFG-AIDS
Full Time
85403BR
Job Summary
The Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital (ZSFG) is an internationally recognized global leader in HIV clinical care, research and education and has grown to encompass a network of specialty clinics, multiple research and clinical trials, an HIV education program, an international research program in East Africa and a vibrant community forum for clinicians and researchers. Housed within the division is the SCOPE (Study on Consequences of Protease Inhibitors Era) and LIINC (Long-term Impact of Infection with the Novel Coronavirus) Research Programs that focuses on clinical and translational research.
The Clinical Research Coordinator (CRC) will work at an independent level to assist the Principal Investigators, project directors, and Senior Clinical Research Coordinators with implementing study protocols, study coordination, data/specimen collection, data management, and quality assurance. The incumbent will recruit, screen, enroll, and follow study participants, and interact with health care providers, clinical researchers, collaborators, funders, and varied administrative and professional staff for a new project known as the PASC-RECOVER (Post-Acute Sequelae of SARS-CoV-2 Infection - Researching COVID to Enhance Recovery) Project.
The final salary and offer components are subject to additional approvals based on UC policy.
Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.
The salary range for this position is $34.32 - $5.19 (Hourly Rate).
To learn more about the benefits of working at UCSF, including total compensation, please visit:
Department Description
The Division of HIV, Infectious Diseases and Global Medicine at UCSF is an internationally recognized global leader in clinical care, research and education. With its home-base located at ZSFG, the Division has been ranked as the top facility in the country for AIDS care for over ten years. The Division's work is featured frequently in the media, and it is often visited by international, national, state and local dignitaries and delegations. The Division consists of approximately 36 faculty members and 140 academic and staff employees. It is the largest Division of the Department of Medicine at ZSFG, with a total expenditure budget of approximately 45 million dollars.
Required Qualifications
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
- Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments, and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
- Experience basic laboratory processing and specimen shipping
Preferred Qualifications
- Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
- Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
- Experience with electronic medical records.
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.).
- Thorough knowledge of antiretroviral medications. Familiarity with treatments for HIV-related infections and medical terminology, research policies and guidelines, guidelines for handling diagnostic specimens including packing/shipping infectious substances
- Certified Safe Shipper - IATA certification
- Database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
- Experience applying the following regulations and guidelines:
- Good Clinical Practice Guidelines
- Health Information and Accountability Act (HIPAA)
- The Protection of Human Research Subjects
- CHR regulations for recruitment and consent of research subjects
- Effective Cash Handling Procedures
- Environmental Health and Safety Training
- Fire Safety Training
- Experience with translational research trials, statistics and/or data management; knowledge of clinical research practices and longitudinal cohort studies
- Experience working with culturally and linguistically diverse groups
- Minimum of two years' experience in clinical, community health setting and/or research setting
- Comfortable interviewing subjects on sensitive issues including high risk sexual practices and illegal drug use
- Knowledgeable in phlebotomy issues, including working knowledge of tubes and procedures required for blood draw of clinical laboratory tests, and sample processing for T-cell assays, flow cytometry, and other research assays; basic laboratory techniques (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage, and disposal of reagents)
- Conversational Spanish language skills with medical terminology
- Demonstrate excellent attendance and reliability. Work during some evening hours and/or early morning hours required
- Advertising/publishing experience a plus.
- Proficient in Microsoft Office programs with emphasis on Excel, Access, Word, Savvy internet user
- Able to carry boxes and supplies weighing up to 20-30 pounds, pack specimens into shipping containers, and deliver specimens to lab in a timely manner. Able to file heavy charts (up to 5 lbs.) in file cabinetsa
About UCSF
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.
Pride Values
UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.
In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
Join us to find a rewarding career contributing to improving healthcare worldwide.
Equal Employment Opportunity
The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.
Organization
Campus
Job Code and Payroll Title
CLIN RSCH CRD
Job Category
Research and Scientific
Bargaining Unit
University Professional Technical Employees - Research Support Professionals Unit (UPTE-RX)
Employee Class
Career
Percentage
100%
Location
San Francisco, CA
Campus
Zuckerberg San Francisco General (ZSFG)
Work Style
Fully On-Site
Shift
Days
Shift Length
8 Hours
Additional Shift Details
Monday - Friday, 8:00am - 5:00pm
Clinical Trials Associate/ Sr Clinical Trials Assoc, Clinical Operations
Posted 4 days ago
Job Viewed
Job Description
SummaryClinical Trials Associate (CTA), Clinical Operations, is responsible for supporting clinical study team(s) to manage various aspects of the operational execution and delivery of quality studies and quality processes according to protocols, SOPs, and Gossamer policies and procedures, applicable regulations and principles of GCP. The CTA will prioritize and handle multiple tasks effectively in a fast-paced Research and Development (R&D) environment. Either under the guidance of Clinical Operations management for the CTA or independently the Sr CTA, the individual will coordinate, track, and manage daily activities for multiple clinical studies to support both the internal project team(s) and the CRO(s).Essential Duties and Responsibilities CTAAssist in the tracking and oversight of all start-up activities (site and country study submissions, clinical trackers and essential documents status) and oversight of third-party vendors.Assist the Clinical Operations Manager(s)/Project Team to prepare and maintain eTMF, ensuring tracking of essential study documents and periodic review to assure accuracy and completeness.Support the Clinical Operations Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.Communicate effectively with clinical study administration vendors (Functional Service providers etc.).Assist in coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.Assist in data listing review and clinical study report listing review.Sr. CTAIn addition to the above, will also be responsible for:Independently tracks and oversees study start-up activities and oversight of third-party vendors.Communicating key issues and mitigations to relevant cross-functional stakeholders.Leads the coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.Actively participates in data listing and/or clinical study report listing review.Contributes to creation of relevant study specific plans, tools and trackers.JOB QUALIFICATIONSEducation, Certifications, ExperienceCTABA/BS in a relevant scientific discipline with 2+ years of experience in supporting clinical trial management for industry sponsored trials. Equivalent combination of education and 5+ years of experience in relevant clinical operations roles may be considered.Sr. CTABA/BS in a relevant scientific discipline with 3+ years of experience in supporting clinical trial management for industry sponsored trials. An equivalent combination of education and 6+ years of experience in relevant clinical operations roles may be considered.Experience being part of a Phase 3 global trial or Phase 2/3 rare disease programs is an asset.Knowledge, Skills and AbilitiesSolid interpersonal skills and demonstrated ability to lead is required.Effective verbal, written, interpersonal and presentation skills are required.Working knowledge and experience with Word, PowerPoint, SharePoint and Excel.Strong attention to detail and dedication to accurate and high-quality work.Focus on results, highly collaborative cross functionally, and proactive.Effective time management skills and ability to manage competing priorities.Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.Hybrid role with frequent onsite visits. Local area candidates highly desirable. SPECIAL WORKING CONDITIONSOffice environment / Domestic and International travel may be necessary (up to 20%).This is a hybrid role requiring frequent onsite visits in San Diego. Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.The expected salary range for this position is $87,000 to $135,000. Actual pay will be determined based on experience, qualifications, geographical location and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit Consumer Privacy Act (CCPA) Notice for California Residents:This notice is to notify you that personal data about you has been collected by Gossamer Bio ("Controller"), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing , because Controller wishes to evaluate your candidacy for employment at Controller.Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller's Privacy team can be contacted at Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.
Clinical Trials Administrative Associate
Posted 3 days ago
Job Viewed
Job Description
The Department of Oncology at the Dell Medical School is looking for a Clinical Trials Administrative Associate. This is a temporary 9 month position, renewable based upon availability of funding, work performance, and progress toward goals.
Assist with administrative tasks in the clinical research department. This position works with the Department of Oncology faculty and staff to facilitate and coordinate administrative, clinical, and financial aspects of multiple research projects. This position requires data entry, file management, document organization, gathering of essential documents, and optimizing feasibility assessments.
Responsibilities:
- Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record information into study-specific data-capture systems (both electronic and paper-based). Resolve and answer data queries with minimal errors. Make independent judgments about the relevance of the clinical data to the research for complicated oncology research subjects. Create and maintain patient shadow charts (paper and eCharts).
- Enter completed patient visits, protocol deviations and additional data points into Clinical Trials Management System. Collaborate with members of Clinical Research Program team to ensure data entry is up to date and accurately reflects activities relating to research. Request medical records and archival tumor tissue when required from outside medical facilities. Independently develop study-specific or program data acquisition forms. Work professionally with research staff to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.
- Principally responsible for maintaining computer spreadsheets and databases for research studies. Understanding research study flow, work with clinic staff support services and research team members. Collate and maintain clinical information from multiple sources into research charts, eCharts, study binders, etc. Help track and maintain research subject schedules based on complex protocol-specific requirements.
- Departmental newsletter creation and distribution, SOP maintenance, and update logs.
- Assist Clinical Research team with tracking laboratory sample supplies, completing requisition forms, and assembling kits for upcoming research subject visits for assigned clinical trials. Assist Clinical Research team with tracking and processing research subject samples following study specific guidelines for storage and/or shipping.
- Other related duties as assigned.
Bachelor's degree in a related field and 1 year of administrative level experience or high school/GED and 5 years of clerical experience. Relevant experience in the medical field. Demonstrated understanding of medical terminology. Strong computer skills, attention to detail and ability to organize work. Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives. Ability to work independently and to carry out complex tasks. Relevant education and experience may be substituted as appropriate.
Preferred QualificationsMore than two years of relevant experience in the medical field. Experience with data entry and databases. Knowledge of Oncology practice and terminology. Prior experience in billing compliance. Prior experience in basic processing and shipping of laboratory samples. Competency in Microsoft Office software. Knowledge of HIPAA regulations. Knowledge of Good Clinical Practice.
Salary Range$32,000+ depending on qualifications
Working Conditions- May work around standard office conditions.
- Repetitive use of a keyboard at a workstation.
- Resume/CV
- 3 work references with their contact information; at least one reference should be from a supervisor
- Letter of interest
Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.
Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.
Employment Eligibility: Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.
Retirement Plan Eligibility: The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.
Background Checks: A criminal history background check will be required for finalist(s) under consideration for this position.
Equal Opportunity Employer: The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.
Pay Transparency: The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
Employment Eligibility Verification: If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.
E-Verify: The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university's company ID number for purposes of E-Verify is . For more information about E-Verify, please see the following:
- E-Verify Poster (English) (PDF)
- E-Verify Poster (Spanish) (PDF)
- Right To Work Poster (English) (PDF)
- Right To Work Poster (Spanish) (PDF)
Compliance: Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031. The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.