Associate Director, Reliance and IRB Operations

New York State Psychiatry Institute•New York, NY

5d•$133,353 - $155,000•Onsite

About The Position

The Research Foundation for Mental Hygiene is seeking a qualified candidate to fill a full-time Associate Director position in the Institutional Review Board (IRB) Office at the New York State Psychiatric Institute (NYSPI) for the Human Research Protection Program (HRPP). Under the supervision of the HRPP Director, the Associate Director of the IRB Office will oversee, implement, and manage all aspects of the operations of NYSPI IRB Office and work as part of the larger NYSPI HRPP to support the protection of human participants in research. The incumbent's core focus will be to oversee NYSPI's IRB Office, build a robust Reliance program, and develop IRB and HRPP policies and procedures, as well as research community tools and resources. The incumbent will direct IRB staff with a focus on reliance activities; provide regulatory guidance to the IRB Office staff, investigators, and Institute leadership; provide support and guidance to investigators in the design and submission of research protocols to external IRBs; and oversee the electronic protocol submission and management system. While working with other HRPP leaders, this individual will be responsible for coordinating education and training to promote the highest standards for the conduct of human subjects research.

Requirements

Bachelor's degree or equivalent related experience.
Minimum of (5) years of progressively responsible experience in IRB administration, research compliance, or a related regulatory field.
Comprehensive knowledge of federal regulations governing human subjects research (e.g., OHRP, FDA, and HIPAA regulations).

Nice To Haves

Advanced degree and (8) years of experience in an IRB or Human Research Protection Office or equivalent related experience.
At least (3)-(5) years of experience in a supervisory or management role
Experience with OneAegis/IRB Manager or a similar electronic IRB management system
Demonstrated experience negotiating and executing IRB reliance agreements
Excellent written and verbal communication, negotiation, and interpersonal skills, with the ability to effectively communicate.
Strong organizational skills, attention to detail, and ability to manage multiple complex tasks simultaneously in a deadline-driven environment.

Responsibilities

Direct all operational and administrative activities of the NYSPI IRB Office, including managing the IRB Office staff and designing, establishing, and maintaining an IRB staffing structure to effectively accomplish the IRB Office program function.
Ensure NYSPI IRB Office staff protocol reviews and those reviews conducted by external IRBs are in compliance with institutional, state, and federal regulations.
Serve as the primary regulatory resource for researchers, sponsors, and study teams, providing guidance on regulatory status, approvals, and participant consent instructions.
Develop, implement, and continuously refine policies, standard operating procedures (SOPs), and tools to support the research community in conducting compliant Human research and governing the NYSPI IRB Office and HRPP functions.
This position will supervise other staff.