Project Associate (Remote), Clinical Trials Office

The SOM Clinical Trials Office (CTO), at the University of Virginia, seeks a Project Associate. The Project Associate is a member of the multisite study management team who supports the administration, conduct, and progress of clinical trials at multiple participating institutions on behalf of the lead investigator at UVA. The incumbent will support the CTO Project Managers assigned to each study. The incumbent is responsible for monitoring the regulatory activities/documents, study data, timelines/milestones of assigned clinical studies and implementing strategies for staying on track.

Project Associate Responsibilities will include:

Supporting CTO Project Managers With Study Start-Up:

• Assist in identifying potential sites. Perform feasibility assessments.
• Assist PI and CTO Project Managers in incorporating multi-site requirements/aspects into a developing protocol.
• Assist in the development of study-related documents, including (but not limited to), study protocol, informed consent template, Manual of Procedures, Case Report Forms, monitoring plan/guidelines, Pharmacy Manual, Lab Manual.
• Work with Database Manager, as applicable, to assist in the development of protocol calendar and data forms. Modify forms when necessary as study evolves.

Supporting CTO Project Managers With Study Study Monitoring and Management:

• Draft and disseminate protocol and/or informed consent modifications to participating sites. Track IRB review and approval process.
• Ensure study staff at participating sites is following the approved protocol and adhering to all applicable regulations/guidelines (e.g., FDA, ICH).
• Conduct drug/device accountability review when applicable.
• Review and confirm subject eligibility for study participation. Register and randomize when applicable.
• Conduct source document verification of data submitted by the study sites, ensuring the quality, integrity and validity of the data collected. Process data queries.
• Monitor study site regulatory documents.
• Participate in the preparation and dissemination of reports for the DSMC/DSMB.
• Manage SAE/DLT information. Prepare and submit reports to the FDA, drug manufacturer and/ or participating sites, as applicable.

Minimum Requirements

Education: Bachelor's degree

Experience: Two years of experience. Relevant experience may be considered in lieu of a degree.

Preferred Qualifications:

• Bachelor's Degree in a science-related field.
• 2-4 years of experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) and/or Research Project Associate.
• Knowledge of GCPs governing clinical research.
• Working knowledge of state and federal guidelines as they apply to the conduct of clinical research.
• Experience with the following computer applications: OnCore, EPIC, Advarra EDC, other clinical trial management systems and electronic data capture system.

PHYSICAL DEMANDS

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

• This position is fully remote*

This is a restricted position and is dependent upon project need, availability of funding and performance. Anticipated Hiring Range: $65,000 - $75,000 commensurate with education and experience. For more information on the benefits at UVA, visit https://hr.virginia.edu/benefits.

This position will remain open until filled. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.

TO APPLY

Please apply through Workday, and search for R0051541. Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'. Complete an application online with the following documents:

• Cover letter
• CV or Resume

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA’s standardized process Skill Survey during the final phase of the interview process. For questions about the application process, please contact Jeremy Brofft, Senior Recruiting Specialist at [email protected].

For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/.

The University of Virginia, including the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician’s Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.