Job location: Charlottesville, VA
Employment Type: Full-time
Posted data: 2020-11-16
The SOM Clinical Trials Office (CTO), at the University of Virginia School of Medicine, seeks a Project Associate .The Research Project Associate is a member of the multicenter study management team who supervises, monitors and supports the administration, conduct, and progress of clinical trials at multiple participating institutions on behalf of the lead investigator at UVA. The incumbent is responsible for monitoring the regulatory activities/documents, study data, timelines/milestones of assigned clinical studies and developing strategies for staying on track. The incumbent is also responsible for ensuring that study personnel at all study sites have the tools they need to conduct the applicable studies according to the clinical protocol, current Good Clinical Practices governing clinical research, and all applicable regulatory requirements.
Project Associate Responsibilities will include:
- Assist PI in incorporating multi-center requirements/aspects into a developing protocol.
- Assist in identifying potential sites. Perform feasibility assessments.
- Develop 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 develop protocol calendar and data forms. Modify forms when necessary as study evolves.
- Develop Trial Master File (sponsor files and investigator files).
- Serve as the liaison between the sites and lead PI (or other assigned personnel) in the negotiation of site budgets.
- Serve as the liaison between the sites and UVA IRB to develop and implement Reliance Agreements for multicenter studies using UVa as the IRB of Record.
- Prepare content and perform initial and continuing training for study personnel at each assigned site.
Study Monitoring and Management:
- Review and confirm subject eligibility for study participation. Register and randomize when applicable.
- Monitor study site regulatory documents.
- Conduct source document verification of data submitted by the study sites, ensuring the quality, integrity and validity of the data collected. Process data queries.
- Conduct drug/device accountability review when applicable.
- Ensure study staff at participating sites is following the approved protocol and adhering to all applicable regulations/guidelines (e.g., FDA, ICH).
- Manage SAE/DLT information. Prepare and submit reports to the FDA, drug manufacturer and/ or participating sites, as applicable.
- Participate in the preparation and dissemination of reports for the DSMC/DSMB.
- Draft and disseminate protocol and/or informed consent modifications to participating sites. Track IRB review and approval process.
- Invoice sponsor per achieved milestones. Receive and reconcile site invoices, request and track site payments.
- Oversee study posting on Clinicaltrials.gov.
- Serve as the point of contact for the site study staff.
- Track, measure and report study/site progress to overall and participating PIs.
- Perform close-out activities for each site upon study completion.
The successful candidate will have a Bachelor's Degree in a relevant discipline. Significant relevant experience may be considered in lieu of a degree. A Bachelor's Degree in a science-related field is preferred. A minimum of 2 years of clinical research experience is required. Prefer 2-4 years of experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) and/or Research Project Associate. Prefer Registered Nurse (RN).
Preferred Skills and Abilities:
- Working knowledge of state and federal guidelines as they apply to the conduct of clinical research.
- Knowledge of GCPs governing clinical research.
- Proficiency with Microsoft Office (Word, Excel and Outlook).
- Prefer experience with the following computer applications: OnCore, other clinical trial management system, electronic data capture system.
Salary will be commensurate with experience and education.
This is a restricted position; continuation is dependent on funding and satisfactory performance.
Priority review of applications will begin on November 26, 2020, but the position will remain open until filled.
EXTERNAL APPLICANTS: please apply through Workday at the following URL, https://uva.wd1.myworkdayjobs.com/UVAJobs , and search for requisition # R0019367. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address). The successful candidate will pass a criminal background check. Please note that multiple documents can be uploaded in the box.
INTERNAL UVA APPLICANTS: please apply through your Workday Home page, search “Find Jobs”, and search for requisition # R0019367. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address). The successful candidate will pass a criminal background check. Please note that multiple documents can be uploaded in the box.
For more information regarding this position, please contact Lori Elder, Director, SOM Clinical Trials Office, at firstname.lastname@example.org.
For more information regarding the application process, please contact Michelle Williams, Faculty Search Advisor at email@example.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.