Regulatory Compliance Coordinator - Charlottesville, United States - University of Virginia

University of Virginia
University of Virginia
Verified Company
Charlottesville, United States

1 week ago

Mark Lane

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Mark Lane

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Description
The School of Medicine Clinical Trials Office is searching for a Regulatory Compliance Coordinator. The coordinator is responsible for independently preparing, processing, submitting and maintaining regulatory documents required for clinical protocols.

This includes preparing and submitting the documents required for review by the IRB of record for each study and other internal review committees, as applicable.

This position works with a team to ensure the efficient and compliant regulatory management of clinical research protocols to which they are assigned.

The incumbent serves as the contact with the relevant internal regulatory committees and sponsor representatives.


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 eregulatory 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

Education:
High school diploma

Experience:
At least two years of relevant experience. Any combination of equivalent education and experience may be considered.


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 open to a hybrid work schedule (expected to work both in-person and remote).*_

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

  • CV or Resume
  • Cover letter
Applications that do not contain all required documents will not receive full consideration.
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