IRB Coordinator

The IRB Coordinator (also called IRB Administrator, IRB Analyst, or Human Subjects Protection Coordinator depending on the institution) is the staff member responsible for the day-to-day administrative operation of an Institutional Review Board (IRB) office. Where the IRB Chair is a voting board member with statutory authority to preside over meetings and make expedited-review determinations, the Coordinator is institutional staff who keeps the review process itself running: intake, scheduling, correspondence, deadline tracking, and recordkeeping.

What makes someone the IRB Coordinator

Operationally, a person is functioning as an IRB Coordinator when their responsibilities center on the office’s process and records rather than on substantive protocol review or board leadership. Typical duties include:

• Protocol intake and completeness screening. Receiving new submissions and amendments from investigators, checking that required documents (protocol, consent forms, recruitment materials) are present, and routing complete submissions for expedited or full-board review.
• Meeting logistics. Scheduling convened meetings, preparing the agenda in coordination with the IRB Chair and Vice Chair, distributing materials to members in advance, and preparing and maintaining meeting minutes.
• Correspondence with investigators. Communicating determinations, requests for clarification, and required modifications back to study teams — often under signature authority the Chair has specifically delegated to IRB staff for routine correspondence, a delegation that institutional written procedures (required under 45 CFR 46.103(b)(4) / 21 CFR 56.108) must define; the underlying determination authority itself remains with the Chair or the convened board regardless of who signs the letter.
• Tracking continuing-review and other regulatory deadlines. Monitoring approval expiration dates and prompting investigators for progress reports and continuing-review submissions well before continuing review is due, since federal regulation requires review at intervals appropriate to the degree of risk but not less than annually for studies subject to it.
• Maintaining IRB records. Keeping the institution’s official record of protocols, approvals, amendments, minutes, and correspondence — the documentation base an institution relies on for its Federalwide Assurance (FWA) compliance and for OHRP evaluations or investigations.

Many institutions support this role with the Certified IRB Professional (CIP®) credential, administered by PRIM&R’s Council for Certification of IRB Professionals. CIP is explicitly aimed at staff with substantial responsibility for overseeing, administering, or performing the daily activities of an IRB within a Human Research Protection Program (HRPP) — the Coordinator role described here, not the Chair’s board-leadership role, which has no equivalent credentialing requirement.

IRB Coordinator vs. IRB Chair

These two roles are frequently conflated because both are central to how an IRB functions day to day, but they sit on opposite sides of a review-versus-operations line:

• IRB Coordinator — institutional staff. Non-voting. Manages intake, scheduling, correspondence, deadline tracking, and records. May hold delegated signature authority for routine correspondence, but not independent review or determination authority.
• IRB Chair — a voting member of the board itself, named on the IRB’s OHRP registration. Presides over convened meetings, calls the vote, and personally holds (or assigns to an experienced reviewer) the statutory authority to conduct expedited review under 45 CFR 46.110.

An institution can and typically does staff these as entirely separate people with different reporting lines — the Coordinator is usually an HRPP/IRB-office employee, while the Chair is a faculty or clinical appointee who volunteers or is assigned board leadership on top of their primary role. Neither substitutes for the other: a Coordinator cannot personally approve, disapprove, or expedite-review a protocol, and a Chair does not typically run the office’s daily intake and scheduling operations alongside board duties.

IRB Coordinator vs. Clinical Research Coordinator (CRC)

The similar job title invites a second, unrelated mix-up. A Clinical Research Coordinator (CRC) works on the investigator’s side of a specific study — screening and consenting participants, collecting study data, managing drug/device accountability — and reports to the Principal Investigator or study sponsor, not to the IRB office. An IRB Coordinator works on the review body’s side, administering the IRB office itself and serving every study submitted to that board, not one specific protocol’s study team.

Worked example

A university’s Biomedical IRB office employs an IRB Coordinator who receives a new protocol submission, checks it against the office’s completeness checklist, flags a missing data-safety plan, and returns it to the investigator with a specific list of what’s needed. Once complete, the Coordinator determines with the Chair whether it qualifies for expedited review or needs the next convened meeting, adds it to the agenda if the latter, and after the meeting drafts the minutes and the approval correspondence, which the Chair has pre-authorized IRB staff to send for routine, unmodified approvals. Six months before the approval’s anniversary, the Coordinator’s tracking system flags the study for continuing review and prompts the investigator for a progress report.

Counter-example

A staff member who reviews a protocol’s scientific or ethical merit and independently decides whether it qualifies for expedited approval is not functioning as an IRB Coordinator in that moment — that is the Chair’s (or a Chair-designated reviewer’s) statutory determination authority. Likewise, a Clinical Research Coordinator managing participant visits and data collection for a single funded study, reporting to a Principal Investigator, is a different role entirely — despite the similar title, they work for the study team, not the review board.

Related CASRAI content

• IRB Chair — the voting board-leadership role this term is distinguished from.
• IRB (Institutional Review Board) — the board itself, its composition and general regulatory basis.
• Continuing Review (IRB) — the recurring deadline the Coordinator is typically responsible for tracking.
• Clinical Research Coordinator (CRC) — the similarly-titled but functionally distinct study-team role.
• IRB/REC Approval Process: What Needs Review and What Doesn’t — how expedited, full-board, and exempt determinations fit together end to end.
• IRB Certification: What It Actually Requires (Training vs. CIP vs. AAHRPP) — the CIP credentialing path referenced above.