Senior Research Regulatory Specialist

About the role

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 physicians and scientists who have helped shape the course of medical history and enriched countless lives. An integral part of NYU Langone Health, the school is committed to improving the human condition through medical education, scientific research, and direct patient care. Equity and inclusion are core values, striving to be a place where faculty, staff, and students of all identities can thrive.

Responsibilities

• Serve as internal project manager for assigned oncology disease groups and provide timely updates on submission status and regulatory guidance.
• Act as liaison between sponsor, CRO, IRB, FDA, and internal departments/staff.
• Initiate contracts and budgets for clinical trials in the internal system (CDAs & CTAs), manage their completion, and ensure timely activation.
• Communicate directly with local and national regulatory authorities.
• Complete site qualification questionnaires from potential industry sponsors and analyze site capability to participate.
• Conduct pre-study visits to confirm site readiness to conduct clinical trials.
• Create regulatory master files for industry and investigator-initiated oncology trials.
• Develop trial-specific patient informed consent forms for highly complex clinical trials (phase 0, 1, 1/2, 2, and 3).
• Contribute to the development and implementation of local protocols and grants, including consent forms, study calendars, LOIs, and single-patient INDs.
• Organize and prepare site initiation visits with sponsor/CRO and clinical team.
• Assist the clinical team in developing trial-specific training tools for study staff.
• Collaborate with investigators to prioritize submission and activation of clinical trials.
• Submit all regulatory documents in a timely manner to meet activation timelines; track and control submissions and disseminate approvals.
• Prepare, submit, and obtain initial approval from mandatory scientific review committees (internal: Protocol Review and Monitoring Committee, IRB, Biosafety Committee, Conflicts of Interest Committee, Radiation Committee; external: FDA, NIH, NCI, Cooperative Groups).
• Provide regulatory counsel and guidance to study members.
• Mentor junior regulatory staff.
• Maintain knowledge of Good Clinical Practice (GCP), clinical research activities, and guidelines related to consent, ethical conduct, and protection of human subjects.
• Aid in the development of departmental standard operating procedures.

Requirements

• Bachelor’s degree.
• 3 years of research-related experience in oncology.
• Working knowledge of government codes and regulations.
• Excellent working knowledge of regulatory compliance requirements and procedures.
• Proficiency with MS Office suites, databases, spreadsheets, graphic, and communications applications.
• Extensive knowledge of oncology clinical trials and oncology terminology.
• Exceptional communication, analytical, presentation, and time management skills.
• Ability to demonstrate impact on project goals through proactive solutions and keep management informed of project schedules and timelines.

Preferred Qualifications

• Master’s degree in a relevant discipline such as Public Health, Health Administration, or a relevant science.
• Minimum of 4 years of comparable experience in hospital planning and operations.

Pay

The salary range for the role is $70,481.60 – $99,750.00 annually. Actual salaries depend on experience, specialty, education, and hospital need. The listed range does not include bonuses, incentive pay, differential pay, or other forms of compensation or benefits.