The Regulatory Manager will play an integral role in the coordination and conduct of clinical trials in the Center for Interventional Vascular Therapy (CIVT) of the Division of Cardiology. The manager will be responsible for managing the overall regulatory processes of all research activities at CIVT.
Prepares and maintains regulatory documents and ensures compliance with human subject regulations and policies.
Prepares IRB initial submissions, amendments, oversees renewal submissions, and other local necessary regulatory approval submissions.
Prepares submissions for the Joint Radiation Safety Committee and oversees submission of JRSC annual submission (being incorporated into RASCAL).
Prepares consent forms; trains pertinent staff members on the maintenance of regulatory documents; and performs internal audits of regulatory documents of protocols on a regular basis.
Ensures regulatory binders are complete. Monitor consents and date of approvals. Participates in investigator meetings, site initiation visits and monitoring visits, if needed. Prepares and updates electronic files for monitoring visits.
Cost Estimates for radiation and anesthesiology cost estimates as needed. Attends various meetings regarding research.
Serves as liaison between investigator and sponsor. Interacts appropriately with the IRB, investigators, Clinical Trials Office, sponsors, clinical research organizations and JRSC as needed.
Supervise regulatory coordinator.
Other responsibilities as assigned.
Bachelor's degree or equivalent in education and experience, plus four years of directly related experience required.
Must successfully complete systems training requirements.
Strong interpersonal skills with focus on teamwork.
Excellent organizational and planning skills.
Excellent oral and written communication skills, attention to detail and ability to meet deadlines and perform multiple tasks required.
Must have experience with the regulatory and financial aspects of clinical trials, IRB protocols and consents.
Training in GCP and HIPAA regulations will be required.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 506214
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.