What are the responsibilities and job description for the Regulatory Affairs Coordinator position at VCU Massey Comprehensive Cancer Center?
The Massey Comprehensive Cancer Center has an exciting opportunity for a Regulatory Affairs Coordinator to join our team! Our employees and applicants come from diverse backgrounds. We hire great people from a wide variety of backgrounds, not just because it’s the right thing to do, but because it makes VCU stronger. Please note flexible work arrangements (Hybrid, Remote) are available for this position within 70 miles of Richmond, Virginia with regular visits to our Downtown Richmond location.
Position Primary Purpose and General Responsibilities
- Deliver exceptional Institutional Review Board (IRB) and related regulatory support to the Principal Investigator (PI) and research team ensuring: 1) adherence to the protocol; 2) regulatory compliance; 3) protection of participant safety and welfare.
- Provide IRB and related regulatory support to the PI and members of the research study team throughout the life of the study (activation to closeout).
- Ensure safety of research participants and endeavor to minimize risk to the institution, center and PI by maintaining audit-ready regulatory files at all times and uploading currently approved protocols, informed consents and PRMC approvals in OnCore upon receipt.
- Monitor study activities to ensure all requisite regulatory approvals are on file prior to the research team consenting / enrolling research participants at Massey or an affiliate site.
- Proficient utilization of electronic research systems/databases to ensure timely submissions and compliance with multiple IRBs and related regulatory entities.
Minimum Qualifications
- Massey Comprehensive Cancer Center supports a diverse faculty, staff, and student environment. The candidate will demonstrate experience that shows their commitment to fostering such an environment.
- Bachelor’s degree or equivalent experience, education and training in an academic medical center
- Independent judgment and critical-thinking skills required.
- Ability to demonstrate successful implementation of time management skills.
- Ability to multi-task and prioritize autonomously.
- Demonstrated leadership experience.
- Exceptional attention to detail and data accuracy.
- Ability to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment.
- Detail-oriented, exceptional organizational skills.
- Proficient with multiple computer applications, including but not limited to: Microsoft Word, Microsoft Excel, spreadsheet management, PDF file creation/use, online database use/maintenance, internet-based research, network & online file maintenance & management, and custom report generation.
- Demonstrated knowledge of medical terminology.
- Ability to provide own transportation to attend meetings within the service area or at training locations.
Preferred Qualifications
- Experience with oncology standard care practice and/or research protocols.
- Experience in clinical research or regulatory management
- Experience with NCI-sponsored cooperative group, private industry and investigator-initiated trials.
- Experience with Oncore or other clinical trial management systems (CTMS).
