Regulatory Compliance Specialist

4 weeks ago


Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Job Summary

The School of Medicine Clinical Trials Office is seeking a highly skilled Regulatory Compliance Coordinator to join their team. As a key member of the team, you will be responsible for ensuring the efficient and compliant regulatory management of clinical research protocols.

Key Responsibilities
  • Prepare and submit regulatory documents to Institutional Review Board (IRB) of record for each study assigned.
  • Submit required documents to internal review committees as applicable.
  • 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.


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