Regulatory Manager - Cardiology

Job Type: Officer of AdministrationRegular/Temporary: RegularHours Per Week: 35Salary Range: $74,500 - $79,500 AnnualThe 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 University's good faith and reasonable estimate of the range of possible compensation at the time of posting.Position SummaryThe 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.ResponsibilitiesPrepare and submit initial IRB applications, amendments, continuing reviews/renewals, and other required regulatory submissionsPrepare submissions to additional oversight committees as required, including the Joint Radiation Safety Committee (JRSC) and other local review bodiesEnsure all regulatory files, approvals, and documentation are current, accurate, and audit-readyMaintain comprehensive regulatory binders and electronic regulatory files for all active protocolsMonitor consent documentation and approval timelines to ensure compliance with human subject protection policiesPrepare and maintain informed consent forms and related regulatory documentsConduct routine internal audits of regulatory files to ensure ongoing complianceServe as primary liaison between investigators, the IRB, Clinical Trials Office, sponsors, CROs, and other institutional departmentsSupport protocol start-up, maintenance, monitoring visits, investigator meetings, and study close-out activitiesPrepare and update regulatory documentation required for site initiation and monitoring visitsProvide cost estimates related to radiation, anesthesiology, and other protocol-specific requirements as neededWork collaboratively with clinical, laboratory, and research staff to support study implementation and conductTrain study staff on regulatory requirements and maintenance of regulatory documentationSupervise and/or mentor regulatory support staff or coordinators, as applicableParticipate in research-related meetings and provide regulatory expertisePerform additional administrative and research-related duties as assignedMinimum QualificationsBachelor's degree or equivalent in education and experience, plus 4 years of related or relevant regulatory experience in clinical research.Preferred QualificationsKnowledge of clinical research regulatory requirements and human subject protection policiesExperience with IRB submissions, regulatory document maintenance, and audit preparednessProficiency with computer systems and electronic regulatory platformsPrior experience supporting investigator-initiated, and industry-sponsored clinical trials preferredOther RequirementsExcellent writing, communication, and organizational skillsStrong attention to detail and ability to manage multiple projects simultaneouslyAbility to work independently with minimal supervision and interact effectively with staff at all levelsMust successfully complete applicable compliance and systems training requirementsEqual Opportunity Employer / Disability / VeteranColumbia University is committed to the hiring of qualified local residents.