Regulatory Manager - Cardiology
556117 Columbia University Medical Center
Medicine
Full Time
Opening on: Mar 19 2026
Grade 105
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Job Type: Officer of Administration
Regular/Temporary: Regular
Hours Per Week: 35
Salary Range: $74,500 - $79,500 Annual
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the Universitys good faith and reasonable estimate of the range of possible compensation at the time of posting.
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
Bachelors 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
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.