Advertised Summary Job Description: Under the direction of the Director of Clinical Research and the supervision of the Regulatory Manager, the Regulatory Coordinator will assist the Regulatory Manager and clinical study teams in the start-up and management of clinical studies in the Division of Nephrology.
The Regulatory Coordinator will assist with IRB and FDA submissions, preparing and maintaining protocol-specific regulatory documents, the initiation, implementation and monitoring of the clinical trial process, and generating monthly &/or ad hoc reports. Will serve as a regulatory contact for studies; ensuring that regulatory compliance is met and that regulatory files are audit-ready. Perform other duties as assigned.
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education, training and experience, plus two years of related experience.
Additional Specific Minimum Qualifications: Excellent verbal and written communication skills and attention to detail is required. Able to verbally communicate effectively with physicians, nurses, pharmaceutical companies and other team members. Able to communicate effectively when reading and writing emails, letter and other reports.
Working knowledge of applicable federal regulations and guidelines associated with complex clinical trials and research involving human subjects. An understanding of and ability to implement institutional policies, procedures and guidelines as established by the CUMC Office of the Executive Vice President for Research and the CUMC Institutional Review Board.
Computer skills (Word, Excel). Must be able to work effectively with minimal supervision. Must be capable of prioritizing and managing several projects at once and take responsibility for meeting deadlines. Must have the flexibility and willingness to occasionally work evenings and weekends in order to meet research trial deadlines.
Successful completion of institutional Human Subjects Protection, Good Clinical Practices (GCP) and HIPAA certifications will be required.
Preferred Qualifications: Experience in an academic or pharmaceutical clinical trials environment preferred.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Internal Number: 126_168887
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.