Research Regulatory Specialist

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.

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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:

1. Regulatory Affairs and Compliance

• 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.
• Monitors study progress and ensures that required regulatory, administrative, and operational milestones are achieved within established timelines.
• Identifies potential barriers to study progression and initiates appropriate actions to facilitate timely resolution.
• Maintains communication with Principal Investigators, research personnel, sponsors, CROs, and institutional departments regarding study status, regulatory requirements, and outstanding deliverables.
• Ensures that study teams are informed of protocol updates, regulatory changes, and applicable compliance requirements.

• Provides oversight and coordination of assigned study activities to promote consistency, efficiency, and adherence to established procedures.

  5. Regulatory Reporting and Documentation

• Prepares and coordinates regulatory and study-related reports for sponsors, funding agencies, institutional offices, and other applicable stakeholders.
• Ensures timely reporting and documentation of protocol deviations, adverse events, unanticipated problems, and other reportable events, in accordance with institutional policies and applicable regulatory requirements.
• Maintains accurate records of regulatory submissions, IRB correspondence, approvals, investigator documentation, and other essential study records.
• Monitors the status of outstanding regulatory requirements and follows up with relevant personnel to ensure timely completion.
• Prepares study progress reports and presentations for institutional leadership, sponsoring agencies, and regulatory stakeholders, as requested.

• May oversee the preparation of study-related databases, tracking tools, and reports to monitor regulatory compliance and study progress.

  6. Grants and Research Funding

• Coordinates and supports the preparation of grant applications, research proposals, and other funding-related documentation, as applicable.
• Collects, reviews, and organizes required supporting documentation for grant submissions.
• Coordinates follow-up activities and assists with the resolution of administrative and documentation-related issues associated with grant applications and ongoing funding obligations.

• Supports the preparation and submission of progress reports and other required deliverables to funding agencies.

  7. Patient Recruitment and Informed Consent Support

• Coordinates and supports participant recruitment activities in collaboration with Principal Investigators and clinical research teams.
• Assists with preliminary eligibility assessments through review of medical records, physician referrals, and other approved recruitment methods.
• Supports the screening process by ensuring that applicable inclusion and exclusion criteria are reviewed and appropriately documented by the study team.
• Assists with the informed consent process, as appropriate and within delegated responsibilities, ensuring that participants receive and understand the required study information.
• Ensures appropriate documentation of consent and other participant-related regulatory requirements.

• Monitors participant-related compliance requirements and coordinates follow-up activities with the research team, as necessary.

  8. Data Reporting and Study Analysis

• Prepares and coordinates study progress reports and data summaries for Principal Investigators, sponsors, and other relevant stakeholders.
• Reviews study-related data and documentation to identify discrepancies, missing information, or inconsistencies that may affect study compliance or reporting.
• Recommends modifications or additions to established data collection fields and tracking systems to improve study oversight and documentation.
• May assist with database development, data organization, and the preparation of comprehensive study reports for review by research leadership.

• Provides oversight and guidance to personnel assigned to study reporting and data management activities, as appropriate.

  9. Staff Training, Guidance, and Development

• Provides regulatory guidance, training, and ongoing support to research coordinators, research assistants, and other research personnel.
• Educates research staff on applicable regulatory requirements, institutional policies, GCP guidelines, and appropriate documentation practices.
• Promotes consistency and accountability in the execution of regulatory and study-related responsibilities.
• Provides mentorship and guidance to less experienced staff and may contribute to staff performance evaluations and professional development.

• Identifies opportunities to improve regulatory workflows, standard operating procedures, and departmental processes.

  10. Decision-Making and Problem Resolution

• Independently evaluates regulatory and operational information to identify potential compliance risks, determine appropriate courses of action, and resolve issues in accordance with established policies and procedures.
• Exercises sound judgment when addressing complex regulatory matters and competing study priorities.
• Identifies and escalates significant compliance concerns, unresolved regulatory issues, and matters requiring Principal Investigator or institutional leadership intervention.
• Participates in departmental initiatives, special projects, and process improvement efforts as assigned.

• Performs other duties as required to support the regulatory and operational needs of the research program.

Minimum Qualifications:

To qualify you must have a Bachelors degree and at least 2 years of research experience. Excellent working knowledge of regulatory compliance requirements and procedures. Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications. Exceptional communication, analytical, presentation and time management skills. Ability to demonstrate impact on project goals through proactive solutions and keeps management aware of project schedules/timelines.

Preferred Qualifications:

Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).
Knowledge of basic medical terminology is preferred.

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.

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NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $66,299.99 - $75,000 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

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