Scientific Research Manager (IRB)

NYU Langone Health • New York, NY

4d • $84,578 - $108,676

About The Position

NYU Grossman School of Medicine is hiring a Scientific Research Manager (IRB). Reporting to the Associate Director of the IRB, the manager oversees IRB submission and review operations, including scientific, ethical, and regulatory oversight of full-board submissions, management of board meetings and staff, and coordination with investigators and other institutional stakeholders. The role also provides coverage for other managers during vacation or sick leave and supports additional work assigned by the Associate Director.

The position oversees submission completeness and regulatory compliance, determines submission pathways and readiness for review, manages review assignments and board documentation, and ensures that board determinations and communications are accurately recorded and issued. It also oversees compliance-related matters, including reportable events, non-compliance, audits, and required reporting to federal agencies. The manager provides guidance and training to IRB staff and participates in education for the research community and IRB members.

Requirements

• An advanced degree.
• Solid command of human-subject regulations and policy.
• Ability to exercise a high degree of independent judgment and discretion regarding research protocol issues.
• Strong organizational, analytical, time-management, multitasking, and interpersonal communication skills.
• Excellent verbal communication and technical writing skills.
• Proficiency with computers and relevant software and database applications, including IRB software, Microsoft Word, and PowerPoint.
• Certified IRB Professional (CIP) certification, or ability to obtain it within one year of employment.
• Ability to communicate effectively with all levels of the organization.

Nice To Haves

• Clinical Research Coordinator (CCRC) certification is listed as preferred; the posting also lists it under certifications in the minimum qualifications.

Responsibilities

• Oversee day-to-day operations for full-board submissions and ensure submissions are reviewed efficiently.
• Conduct scientific, ethical, and regulatory oversight of full-board submissions, including verifying completeness, accuracy, and compliance with institutional policies, applicable laws, and good clinical practices.
• Determine whether submissions require an IND or IDE and make final readiness determinations for new protocols, continuations, and amendments before board assignment.
• Review initial full-board agenda items in preparation for meetings of Boards A, B, C, D, F, and G.
• Determine which submissions qualify for expedited review and coordinate appropriate review with HRP staff.
• Conduct comprehensive pre-review of reportable events and make determinations under the NYU SOM RNI policy.
• Lead prebriefings with IRB staff and the IRB Chair, and lead or oversee post-meeting debriefings to clarify board determinations.
• Attend board meetings, including Board E compliance meetings; serve as a voting member and help manage meetings and post-review responsibilities.
• Manage IRB meeting activities, minutes, agendas, reviewer assignments, post-review decisions, and follow-through to final outcomes.
• Assign primary reviewers equitably and by specialty, and verify that reviewers have no conflicts of interest.
• Ensure meeting minutes document controverted issues, their resolution, and board determinations; develop and distribute minutes for review and approval.
• Create and issue board determination letters for initial submissions, including deferrals, required modifications, and approvals; review letters for modification and continuation submissions before release by a Senior Analyst.
• Manage compliance-related determination letters, including findings of non-compliance, serious or continuing non-compliance, and study suspension.
• Prepare board correspondence concerning non-compliance and coordinate with the Senior Director, HRP, Office of General Counsel, and NYC Health + Hospitals as applicable.
• Disseminate reportable non-compliance letters and ensure timely reporting to investigators, institutional leadership, OHRP, FDA, and other relevant agencies.
• Maintain logs of non-compliance, unanticipated problems, federal correspondence, allegations, and audit or RNI action items; follow up with principal investigators on outstanding matters.
• Oversee responses to deferrals, assess readiness for IRB re-review, communicate review issues to principal investigators through Research Navigator, and ensure research-team communications are recorded there.
• Oversee outstanding issues resulting from study deferrals and follow up with principal investigators to ensure completion.
• Perform designated reviews of submissions eligible for expedited procedures and responses to conditional approvals; conduct full-board new-study reviews from submission through approval when required.
• Provide guidance and training to full-board IRB staff on submission activities.
• Conduct regular quality-control reviews with the Associate Director twice a year.
• Develop presentations and participate in education and training for the research community, IRB staff, and IRB members in collaboration with the IRB Education Manager.
• Provide coverage for other managers' responsibilities when needed, including agendas, letter review, staff direction, and communication with research teams.
• Provide additional support and assistance as required by the Associate Director.

Benefits

• Comprehensive benefits and wellness package.
• Financial security benefits.
• Generous time-off program.
• Employee resource groups for peer support.
• Employee wellness program covering physical, mental, nutritional, sleep, social, financial, and preventive care.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager