Regulatory Affairs Clinical Research Coordinator

2 weeks ago

Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Position Overview

The Commonwealth of Virginia is seeking qualified candidates for the role of Regulatory Clinical Research Coordinator within the Cancer Center's Office of Clinical Research (CC OCR). This pivotal role involves the independent submission and management of clinical research protocols for regulatory assessment by various committees and authorities, including the Protocol Review Committee (PRC), Institutional Review Board (IRB), and the FDA. The successful candidate will collaborate closely with the OCR Regulatory Manager to ensure that clinical research protocols are managed efficiently and in compliance with all regulatory requirements.

Key Responsibilities:
  • Prepare and submit documentation for the Protocol Review Committee (PRC).
  • Draft concise protocols and consent forms for Institutional Review Board (IRB) submission.
  • Facilitate expedited submissions to the Central Institutional Review Board (CIRB).
  • Manage adverse events, amendments, personnel changes, and safety reports.
  • Utilize the OnCore informatics platform to maintain regulatory compliance.
  • Organize and oversee both physical and electronic trial documentation.
  • Compile and maintain essential regulatory documents for clinical trials.
  • Collaborate with clinical trial sponsors to ensure adherence to protocol requirements.
  • Submit Informed Consent Form (ICF) language to the relevant committees.
  • Respond to reports from the Data and Safety Monitoring Committee (DSMC).
  • Prepare responses for internal Post Approval Monitoring (PAM) audits.
  • Ensure timely adherence to deadlines and edit materials as required by governing bodies.
  • Assist in the preparation and organization of regulatory documentation for clinical trials.
  • Notify the Principal Investigator and/or supervisor of any changes in study regulatory status.
  • Provide comprehensive study information to the Principal Investigator, supervisory personnel, and interdisciplinary team members.
  • Act as the primary liaison with sponsors for assigned studies.
  • Generate study status reports as necessary.
  • Stay informed on federal, state, and local regulations governing clinical trial activities.
  • Participate in team meetings to discuss ongoing projects.
Minimum Qualifications:

Compliance Coordinator Trainee:
Education: High School Diploma
Experience: None required; some experience in a healthcare environment preferred.

Compliance Coordinator:
Education: High School Diploma
Experience: Minimum of 2 years of relevant experience.

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 application, including a CV/resume and a cover letter. All documents should be uploaded into the resume submission field. Incomplete applications will not be considered.

The Commonwealth of Virginia is committed to diversity and inclusion within its workforce. We are an equal opportunity employer and welcome applications from all qualified individuals without regard to 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.

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