Advisor, Institutional Review Board

Job Description

Provides expert advice and guidance on research compliance matters related to the Institutional Review Board (IRB). Supports investigators and IRB staff in navigating the complexities of human subjects research regulations, ensuring adherence to federal, state, and local requirements, and promoting ethical research conduct within Northwell Health. This role requires a deep understanding of Human Research Protection Program (HRPP)/IRB functions, compliance regulations, and the ability to develop and implement strategic compliance initiatives. This is a fully remote role.

Job Responsibility

1. Serves as the primary point of contact for researchers and IRB staff regarding compliance-related inquiries, providing expert guidance and interpretation of regulations.
2. Reviews research proposals to determine appropriate review categories, assess risk, and identify areas requiring further clinical or professional evaluation.
3. Supports IRB committee functions, including preparing compliance submissions, attending meetings, and drafting minutes related to compliance matters.
4. Oversees reporting and communication with federal agencies (e.g., OHRP, FDA) on compliance matters and reportable events.
5. Conducts internal audits of HRPP/IRB processes and external audits of research studies to ensure compliance and readiness for external reviews.
6. Develops and delivers training programs on human subjects research regulations for IRB members, staff, and researchers.
7. Collaborates with Legal Affairs and the Office of Research Compliance to develop and implement compliance policies and address non-compliance issues.
8. Manages the Reportable Events Committee (REC) to evaluate and address potential reportable events for externally reviewed studies.
9. Recommends compliance-related policy revisions to the HRPP/IRB leaders.
10. Maintains up-to-date knowledge of human subjects protection regulations.
11. Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related, are not essential functions.

Job Qualification

*Bachelor's Degree required, or equivalent combination of education and related experience.
*10+ years of relevant experience and 2+ years of leadership/mgmt experience, required.

*Additional Salary Detail
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).