Research Regulatory Specialist

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.