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 spend approximately 60% of the time at 400 Kelby St. Fort Lee, NJ and 40% of the time at the Columbia University Medical Center in New York, NY.
Coordinates all aspects of protocol submission for research projects. (25%)
Ensures regulatory approvals for all required components of human subjects research/clinical trials are obtained and maintained accordingly. (45%)
Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors. (15%)
Serves as an integral part of disease specific research teams. (10%)
Performs other miscellaneous tasks as needed. (5%)
Bachelor's Degree or equivalent in education and experience, plus two years of related experience
Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.
Excellent interpersonal and organizational skills.
Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 507988
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.