An IRB Manager (also titled IRB Administrator, Human Research Protection Program Manager, or HRPP Director depending on the institution) is the staff member who runs the operations of an Institutional Review Board office as a whole — supervising IRB staff, maintaining the institution’s regulatory standing with federal oversight bodies, and administering the human research protection program (HRPP) that the board sits inside. It is a distinct, more senior tier than the IRB Coordinator role: where a Coordinator handles the day-to-day intake, scheduling, and correspondence for individual protocol reviews, the Manager is responsible for the office’s staffing, policy, systems, and regulatory compliance as a program.
This guide covers what an IRB Manager actually does, how the role differs from the Coordinator, Administrator, and Chair titles it’s often confused with, and where it typically sits in an institution’s reporting structure. For the review process itself, see IRB/REC Approval Process: What Needs Review and What Doesn’t and The IRB Application: What to Include, How to Prepare It, and Why It Gets Sent Back.
What an IRB Manager actually does
Job titles vary considerably by institution size and type — a large academic medical center may have an IRB Manager overseeing several Coordinators across multiple boards, while a smaller institution may combine the Manager and Coordinator functions into a single “IRB Administrator” position. Regardless of title, the responsibilities that distinguish the managerial tier from coordinator-level work tend to cluster around five areas:
- Staff supervision. Hiring, training, and supervising IRB Coordinators and other office staff; setting workload and quality standards for protocol intake and review-cycle turnaround.
- HRPP policy and SOP development. Drafting and maintaining the institution’s written policies and procedures for human subjects protection — including the delegation of correspondence and signature authority that 45 CFR 46.103(b)(4) and 21 CFR 56.108 require institutions to define in writing, even though the underlying review determination itself stays with the board or its Chair.
- Regulatory standing and reporting-line liaison. Maintaining the institution’s Federalwide Assurance (FWA) and IRB registration with OHRP, and acting as the operational point of contact between the IRB office and the institution’s Designated Institutional Official (DIO) — the senior official who signs the FWA and holds ultimate institutional accountability for the human research protection program.
- Accreditation and quality assurance. Preparing self-assessment materials and evidence files for AAHRPP accreditation or reaccreditation, running internal quality-improvement audits of protocol files, and tracking metrics such as review-cycle time and continuing-review compliance rates.
- Systems and budget administration. Selecting, configuring, and administering the electronic IRB submission/tracking system the office runs on (commonly cited commercial platforms include Cayuse, IRBManager, Click Commerce/Huron, and Kuali), and managing the office’s operating budget, including any commercial IRB review fees for externally-reviewed studies.
IRB Manager vs. IRB Coordinator vs. IRB Chair vs. IRB Director
Because “IRB Administrator” is used inconsistently across institutions — sometimes as a synonym for Coordinator, sometimes for Manager — it helps to separate the roles by what they’re actually accountable for rather than by title alone:
- IRB Coordinator — operational, protocol-by-protocol work: intake screening, meeting logistics, correspondence, and continuing-review deadline tracking. Typically the entry point into IRB administration as a career track.
- IRB Manager / IRB Administrator (senior use) — program-level responsibility: supervises Coordinators, owns SOPs and systems, and is the office’s operational lead. This is the role this guide describes.
- IRB Chair — a voting board member with statutory authority to preside over convened meetings and make expedited-review determinations under 45 CFR 46.110 / 21 CFR 56.110. The Chair is a regulatory decision-maker, not institutional staff, and does not supervise the IRB office’s employees — a structural distinction from the Manager role even though the two work in close coordination.
- HRPP Director / Director of Research Compliance — at larger institutions, a role above the IRB Manager with authority spanning multiple committees (IRB, and often IACUC or the conflict-of-interest office as well) and direct reporting to the Institutional Official.
Credentials and career path
There is no single mandatory credential for the role, but the Certified IRB Professional (CIP) credential — administered by the PRIM&R-affiliated Council for Certification of IRB Professionals (CCIP), requiring a written exam and periodic recertification — is the most widely recognized professional certification in the field and is commonly listed as preferred or required in IRB Manager job postings. Many IRB Managers progress into the role after several years as an IRB Coordinator, and some move on to HRPP Director or broader research-compliance leadership positions from there. See IRB Certification: What It Actually Requires (Training vs. CIP vs. AAHRPP) for how the CIP credential relates to institutional AAHRPP accreditation, which is a program-level certification rather than an individual one.
Where the role sits organizationally
The IRB Manager typically reports to the Designated Institutional Official directly, or to an HRPP Director or Director of Research Compliance who in turn reports to the DIO — commonly a senior research or academic-affairs official such as a Vice President/Vice Provost for Research. The Manager does not report to the IRB Chair; the Chair and Manager are parallel roles (regulatory authority vs. operational management) that coordinate closely but sit in separate lines of accountability, which is one of the more common points of confusion for people new to research-administration organizational charts.
Frequently asked questions
Is “IRB Manager” the same job as “IRB Administrator”?
Sometimes, but not consistently. Some institutions use “IRB Administrator” as a synonym for Coordinator-level work; others use it for the more senior, program-level Manager role described here. Read the actual job description’s scope — particularly whether it includes staff supervision and SOP ownership — rather than relying on the title alone.
Does an IRB Manager need to be a scientist or have a research background?
No specific degree or research background is federally mandated for IRB staff positions. Institutions vary in their hiring preferences; many value regulatory, compliance, or healthcare-administration backgrounds alongside or instead of a research science degree, and the CIP credential is generally viewed as more relevant to hiring than a specific academic discipline.
What software do IRB Managers typically administer?
Most mid-size and large institutions run their IRB submission and tracking process through a dedicated electronic system rather than paper or generic document management. Commonly cited commercial platforms include Cayuse, IRBManager, and Click Commerce/Huron Research Suite, among others; the Manager is typically the office’s system administrator for whichever platform the institution has licensed, responsible for configuration, user access, and reporting rather than for evaluating competing vendors as a primary job function.
How does the IRB Manager role relate to IACUC or biosafety committee management?
They’re structurally similar but regulatorily distinct — IACUC and Institutional Biosafety Committee coordinators/managers exist under separate frameworks (the Animal Welfare Act and PHS Policy for IACUC; NIH Guidelines for biosafety) and are typically separate positions, though at smaller institutions one Research Compliance office may house all three functions under a single director.
