Under the direction of the Associate Director of Regulatory Affairs and the supervision of the Regulatory Manager, the Regulatory Coordinator will assist in the start-up and management of clinical studies in the CPDM office. The Regulatory Coordinator will assist with IRB and FDA submissions and preparing/maintaining protocol-specific regulatory documents for the initiation, implementation, ongoing monitoring, and formal closure of assigned clinical trials. Will serve as a primary regulatory contact for studies (for both internal and external stakeholders); ensuring that regulatory compliance is met and that regulatory files are audit-ready. This position will report to Fort Lee, NJ 60% of the time and to the Columbia University Irving Medical Center in New York City 40% of the time.Apply Now
- Coordinates all aspects of protocol submission for research projects. (25%)
- Prepares and submits all necessary documents to the Institutional Review Board (IRB) and Protocol Review Monitoring Committee (PRMC), and ancillary committees
- Ensures regulatory approvals for all required components of human subjects research/clinical trials are obtained and maintained accordingly. (45%)
- Annual IRB renewal submissions and ancillary review committee annual reports
- FDA annual reports (as needed)
- Timely submission of all required documents
- Official reporting of Unanticipated Problems to the IRB of record (as applicable)
- Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors. (15%)
- Assists in preparations for routine monitoring and audit visits for assigned clinical trials
- Serves as an integral part of disease specific research teams. (10%)
- Attend and present at recurring research team meetings
- Maintains and disseminates accurate listings of active and potential studies to participating investigators
- Serves as the resource for current regulatory information/statuses for assigned protocols
- Performs other miscellaneous tasks as needed. (5%)
- Bachelor’s Degree or equivalent in education and experience, plus two years of related experience
- Excellent interpersonal and organizational skills.
- Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
- Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.