Regulatory Compliance Coordinator

6 days ago

Charlottesville, Virginia, United States Commonwealth of Virginia Full time
The School of Medicine Clinical Trials Office is seeking a Regulatory Compliance Coordinator

The Regulatory Compliance Coordinator is in charge of independently preparing, processing, submitting, and maintaining essential regulatory documents for clinical protocols at the School of Medicine. This crucial role involves ensuring the timely submission of documents for review by the relevant internal committees as well as sponsors. Working collaboratively with a team, the coordinator plays a key role in maintaining efficient and compliant regulatory processes for assigned clinical research protocols.

JOB RESPONSIBILITIES
  • Prepare and submit protocol, informed consent form (ICF), and all required documents to the Institutional Review Board (IRB) for each study.
  • Submit necessary documents to internal review committees such as HIRE.
  • Meet committee and sponsor deadlines, make document edits as necessary, and monitor the review and approval progress.
  • Keep Principal Investigator (PI) and Clinical Research Coordinator (CRC) updated on progress.
  • Draft, process, collect, and maintain essential regulatory documents.
  • Submit adverse events reports, protocol amendments, personnel changes, and other required documents.
  • Ensure regulatory compliance using management systems.
  • Collaborate with sponsors on regulatory document compliance.
  • Prepare responses to quality assurance reviews and other findings.
  • Inform relevant parties of study regulatory status changes.
  • Provide accurate study information to stakeholders.
  • Serve as the main contact with sponsors.
  • Prepare study status reports.
  • Stay updated on regulations governing clinical trials.
  • Attend team meetings.
MINIMUM REQUIREMENTS

Education: High school diploma
Experience: Minimum of two years of relevant experience or equivalent education.

PHYSICAL DEMANDS

This role involves primarily sedentary work with considerable computer use and occasional travel for meetings.

*This role allows for a hybrid work schedule, combining in-person and remote work.*

TO APPLY

To apply for this position, visit the Careers at UVA website and search for the job posting. Internal applicants should apply through their UVA Workday profile by searching 'Find Jobs'. Ensure your application includes a CV or Resume and a Cover letter to be considered for the role.

References will be obtained through UVA's standardized process Skill Survey during the final interview stage. For inquiries about the application process, reach out to Jeremy Brofft, Senior Recruiting Specialist.

The University of Virginia is strongly committed to diversity and equal opportunity employment. Qualified applicants will be evaluated without regard to various factors including age, disability, gender identity, national origin, race, religion, and more.

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