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Clinical Research Regulatory Specialist

2 months ago

Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Position Overview
The Commonwealth of Virginia is seeking dedicated individuals to join our team as Regulatory Coordinators within the Cancer Center's Office of Clinical Research (CC OCR). The Regulatory Coordinator will play a crucial role in the independent submission and management of cancer research protocols for regulatory evaluation by various committees and authorities. This position collaborates closely with the OCR Regulatory Manager to ensure the effective and compliant oversight of clinical research protocols across the Cancer Center.

Key Responsibilities
  • Prepare and submit documents for Protocol Review Committee (PRC) evaluations.
  • Draft concise protocols and consent forms for Institutional Review Board (IRB) submission.
  • Manage expedited submissions to Central Institutional Review Boards (CIRB).
  • Oversee the processing of adverse events, amendments, personnel changes, and safety reports.
  • Ensure regulatory compliance utilizing the OnCore informatics platform.
  • Maintain both physical and electronic trial documentation.
  • Collect and organize essential regulatory documents for clinical trials.
  • Collaborate with clinical trial sponsors to uphold protocol adherence.
  • Submit Informed Consent Form (ICF) language to the appropriate committees.
  • Address reports from the Data and Safety Monitoring Committee (DSMC).
  • Prepare responses for internal Post Approval Monitoring (PAM) audits.
  • Adhere to submission deadlines and modify materials as directed by governing boards.
  • Assist in the preparation and organization of regulatory documentation for clinical trials.
  • Inform the Principal Investigator and supervisor of any changes in study regulatory status.
  • Provide accurate and comprehensive study information to all relevant parties.
  • Act as the liaison with sponsors for assigned studies.
  • Generate study status reports as required.
  • Stay informed about federal, state, and local regulations governing clinical trial activities.
  • Participate in team meetings.

Minimum Qualifications
  • Compliance Coordinator Trainee: High School Diploma; no prior experience required, although some experience in a healthcare setting is preferred.
  • Compliance Coordinator: High School Diploma; a minimum of 2 years of relevant experience is required.

Physical Requirements
This role primarily involves sedentary work with extensive use of desktop computers.

Compensation
  • Compliance Coordinator Trainee: $45,000-$50,000
  • Compliance Coordinator: $51,000-$56,000

Application Process
Interested candidates are encouraged to submit their applications, including a CV/resume and a cover letter. All documents should be uploaded into the resume submission field. Incomplete applications will not be considered.

Diversity Commitment
The Commonwealth of Virginia is committed to fostering a diverse workforce and encourages applications from all qualified individuals, regardless of age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex, sexual orientation, veteran status, and family medical or genetic information.