Research Regulatory Specialist

NYU Langone; New York (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

NYU Langone Health's Grossman School of Medicine invites applications for a Research Regulatory Specialist. This role acts as primary liaison between sponsors, CROs, IRBs, and internal teams to ensure regulatory oversight and compliance of clinical studies.

You will manage submissions, maintain study documentation, monitor approvals, and support audits, trainings, and investigator documentation across multiple studies.

Responsibilities

• Coordinates and oversees regulatory activities for assigned clinical research studies, ensuring compliance with applicable regulations.

Job description

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, X and Instagram.

Position Summary:

We have an exciting opportunity to join our team as a Research Regulatory Specialist.

Serves as a primary liaison between research sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and internal departments and research personnel to facilitate the regulatory oversight, compliance, and administration of clinical research studies. Ensures that all research activities are conducted in accordance with approved study protocols, Good Clinical Practice (GCP) guidelines, institutional policies, HIPAA regulations, and applicable federal and state regulatory requirements.

Oversees and coordinates regulatory submissions, maintains essential study documentation, monitors regulatory compliance throughout the study lifecycle, and ensures that required approvals, amendments, continuing reviews, and study-related reporting are completed accurately and within established timelines. Collaborates closely with Principal Investigators (PIs), research teams, sponsors, CROs, and institutional regulatory offices to support the compliant and efficient execution of clinical research activities.

Provides regulatory guidance, training, and support to research personnel and ensures that study teams remain informed of applicable regulatory requirements and institutional procedures. May interface directly with research participants, as appropriate, to support informed consent and study-related activities.

Works independently and exercises sound judgment in managing regulatory responsibilities, resolving compliance-related issues, and coordinating multiple studies with limited oversight.

Job Responsibilities:

• Coordinates and oversees regulatory activities for assigned clinical research studies, ensuring compliance with applicable federal regulations, institutional policies, IRB requirements, GCP guidelines, and HIPAA regulations.
• Prepares, reviews, coordinates, and submits regulatory documentation to the NYU Institutional Review Board (IRB), NYU Office of Clinical Trials, and other applicable regulatory bodies.
• Oversees the preparation and submission of initial study applications, protocol amendments, continuing reviews, safety reports, deviations, personnel changes, and study closure documentation, as applicable.
• Ensures that all regulatory submissions are accurate, complete, and submitted within established institutional and regulatory timelines.
• Maintains current and organized regulatory files, ensuring the accuracy, completeness, and availability of essential study documentation throughout the study lifecycle.
• Monitors regulatory approval status, expiration dates, and outstanding requirements to ensure uninterrupted study compliance.
• Serves as a regulatory resource to Principal Investigators and research staff, providing guidance on regulatory requirements, institutional policies, and appropriate documentation practices.
• Identifies potential compliance concerns, discrepancies, or regulatory deficiencies and coordinates appropriate corrective actions with the Principal Investigator and relevant institutional departments.
• Supports regulatory inspections, sponsor audits, and internal quality assurance reviews, including the preparation and retrieval of requested documentation. 2. Protocol and Study Start-Up Management
• Reviews study protocols and related documentation to identify regulatory requirements, operational considerations, and study-specific obligations.
• Coordinates study start-up activities, including the collection, review, and submission of required regulatory and institutional documentation.
• Collaborates with Principal Investigators, sponsors, CROs, and internal departments to facilitate timely study activation and ensure all necessary approvals and documentation are in place prior to study initiation.
• Reviews sponsor-provided regulatory documents for completeness and consistency with institutional and regulatory requirements.
• Coordinates the collection and maintenance of required investigator documentation, including CVs, medical licenses, training certifications, financial disclosures, and other essential regulatory records.
• Participates in protocol development and the identification of potential research opportunities and sponsors, as assigned. 3. Financial and Budgetary Oversight
• Develops preliminary study budgets and evaluates resource requirements based on protocol-specific activities and operational demands.
• Reviews sponsor-proposed budgets to assess financial feasibility and ensure adequate coverage for study-related procedures, personnel, and administrative responsibilities.
• Recommends budget modifications and appropriate staffing levels in collaboration with the study or project leader.
• Monitors study budgets throughout the trial and identifies potential financial discrepancies or resource needs.
• Prepares funding reports and financial documentation for sponsors, funding agencies, and institutional stakeholders, as required. 4. Study Oversight and Project Management
• Coordinates and oversees the regulatory and operational activities of multiple clinical research studies and projects