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Regulatory Coordinator
Columbia University
Position Summary 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. Responsibilities
Minimum Qualifications
Preferred Qualifications
Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
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