Regulatory Manager - Cardiology

Position Summary

The Columbia University Department of Medicine, Division of Cardiology - Heart Failure and New York Presbyterian Heart Failure Research Institute is seeking a Regulatory Manager to join its clinical research team. This individual will provide comprehensive regulatory oversight and operational support for a diverse portfolio of clinical research studies including investigator-initiated HFRI studies, and industry-sponsored clinical trials.

The Regulatory Manager will play an integral role in the coordination and conduct of clinical trials and will be responsible for managing the overall regulatory processes for all research activities within the division. This position requires a highly organized and experienced regulatory professional who can work independently, maintain compliance across multiple studies, and serve as a key liaison between investigators, regulatory bodies, sponsors, and institutional offices.

Responsibilities

• Prepare and submit initial IRB applications, amendments, continuing reviews/renewals, and other required regulatory submissions
• Prepare submissions to additional oversight committees as required, including the Joint Radiation Safety Committee (JRSC) and other local review bodies
• Ensure all regulatory files, approvals, and documentation are current, accurate, and audit-ready
• Maintain comprehensive regulatory binders and electronic regulatory files for all active protocols
• Monitor consent documentation and approval timelines to ensure compliance with human subject protection policies
• Prepare and maintain informed consent forms and related regulatory documents
• Conduct routine internal audits of regulatory files to ensure ongoing compliance
• Serve as primary liaison between investigators, the IRB, Clinical Trials Office, sponsors, CROs, and other institutional departments
• Support protocol start-up, maintenance, monitoring visits, investigator meetings, and study close-out activities
• Prepare and update regulatory documentation required for site initiation and monitoring visits
• Provide cost estimates related to radiation, anesthesiology, and other protocol-specific requirements as needed
• Work collaboratively with clinical, laboratory, and research staff to support study implementation and conduct
• Train study staff on regulatory requirements and maintenance of regulatory documentation
• Supervise and/or mentor regulatory support staff or coordinators, as applicable
• Participate in research-related meetings and provide regulatory expertise
• Perform additional administrative and research-related duties as assigned

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience, plus 4 years of related or relevant regulatory experience in clinical research.

Preferred Qualifications

• Knowledge of clinical research regulatory requirements and human subject protection policies
• Experience with IRB submissions, regulatory document maintenance, and audit preparedness
• Proficiency with computer systems and electronic regulatory platforms
• Prior experience supporting investigator-initiated, and industry-sponsored clinical trials preferred

Other Requirements

• Excellent writing, communication, and organizational skills
• Strong attention to detail and ability to manage multiple projects simultaneously
• Ability to work independently with minimal supervision and interact effectively with staff at all levels
• Must successfully complete applicable compliance and systems training requirements