Regulatory Coordinator

4 weeks ago

Charlottesville, United States University of Virginia Full time

**JOB RESPONSIBILITIES**
- Prepare and submit protocol, informed consent form (ICF), and all required documents to Institutional Review Board (IRB) of record for each study assigned.
- Submit required documents to internal review committees as applicable (e.g. HIRE).
- Adhere to committee and sponsor deadlines, edit documents as requested by review committees, and follow progress of the review and approval process of each committee.
- Communicate progress with Principal Investigator (PI) and Clinical Research Coordinator (CRC).
- Draft, process, collect and maintain essential regulatory documents.
- Process and submit adverse events reports, protocol and informed consent amendments/revisions, personnel changes, study continuations, Investigational New Drug (IND) safety reports, protocol deviations, and investigator brochures.
- Maintain regulatory compliance utilizing the clinical trial management system and the e-regulatory system. Administer and maintain physical and electronic trial files, as applicable.
- Collaborate with clinical trial sponsors to maintain regulatory document compliance.
- Prepare and transmit responses to findings generated from internal and external quality assurance reviews, monitoring visits, and/or audits.
- Notify PI and/or supervisor of study regulatory status changes.
- Convey accurate and comprehensive study information to PI, CRCs, supervisory personnel, study sponsor, members of the interdisciplinary team involved in the studies, and peers.
- Serve as the liaison with the sponsor for all assigned studies.
- Prepare study status reports as required.
- Keep current in federal, state and local regulations governing clinical trial activities and performs all activities in compliance with these regulations.
- Attend team meetings.

**MINIMUM REQUIREMENTS**:
**Compliance Analyst**:
Education: Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.
Experience: At least two years of relevant experience.
- Anticipated Hiring Range: $50,000 - $60,000, commensurate with education and experience._

**Senior Compliance Analyst**:
Education: Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.
Experience: Four years of relevant experience.
Licensure: Subject matter licensure may be required.
- Anticipated Hiring Range: $65,000 - $80,000, commensurate with education and experience._

**PREFERRED QUALIFICATIONS**
- Prior experience as a Clinical Research Coordinator.
- Knowledge of submitting to central IRBs.
- Experience with electronic regulatory systems.

**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 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.

This position will not sponsor applicants for work Visas.

**TO APPLY**
- CV or Resume
- Cover letter

Applications that do not contain all required documents will not receive full consideration.

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