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.
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.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 505828
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.