IRB Operations Manager

Vitalief•Princeton, NJ

5d•Hybrid

About The Position

We are seeking an experienced IRB Operations Manager to join Vitalief as a full-time employee to initially provide leadership and operational support for one of Vitalief’s research clients’ Human Subjects Protection Program (HSPP). This resource will oversee the day-to-day operations of the HSPP, ensuring effective administration of institutional review processes, regulatory compliance, and protection of human research participants. The ideal candidate will bring significant experience in IRB administration, human subjects research protections, federal research regulations, and program operations, with the ability to quickly assess processes, provide leadership continuity, and maintain high-quality service delivery.

Requirements

Bachelor’s degree required; advanced degree preferred.
5 or more years’ experience in human subjects research oversight and day-to-day IRB regulatory operations administration.
Experience leading day-to-day IRB regulatory operations, including supervising staff members while ensuring regulatory compliance.
Strong knowledge of Common Rule (45 CFR 46); FDA human subjects research regulations (as applicable); Ethical principles governing research involving human participants; Exempt, expedited, and full board review processes.
Experience managing IRB submissions and regulatory workflows.
Experience working with convened IRB committees.
Demonstrated ability to interpret and apply complex research regulations and institutional policies.
Strong organizational, analytical, and communication skills.

Nice To Haves

Experience supporting academic research environments is preferred.
Familiarity with Huron/eRIA or similar electronic research administration systems.
Experience supporting both social/behavioral research and biomedical/clinical research portfolios is a plus.

Responsibilities

Lead day-to-day operations of the HSPP, supervising three full-time staff while ensuring regulatory compliance and efficient workflow.
Serve as subject matter expert on human subjects research protections, ethics, and applicable federal regulations.
Oversee processing of all research submissions (new protocols, continuing reviews, amendments, reportable events) across exempt, expedited, and convened review pathways.
Provide regulatory guidance to investigators and research teams on human subjects protection requirements.
Coordinate pre- and post-meeting activities, ensure quality of review materials, and approve meeting minutes for two monthly IRB meetings (one in-person, one remote).
Identify operational efficiencies and partner with researchers, compliance teams, and administrative stakeholders to resolve regulatory issues and deliver training.
Manage protocol workflows, reporting, and recordkeeping through the Huron/eRIA research administration platform.