IRB Program Manager Full Time Days

BASIC PURPOSE OF THE JOB

The IRB Program Manager directs the administrative and regulatory operations that enable the IRB and institution to fulfill applicable federal human-subject protection requirements. Responsibilities include committee administration; submission intake and regulatory routing; maintenance of IRB membership, rosters, records, and minutes; required communications and reporting; written-procedure governance; continuing oversight workflows; CIRB/reliance administration; quality assurance; education; and readiness for regulatory inspection or audit.

REPORTS TO

Director of Quality, Patient Safety, and Medical Affairs

JOB REQUIREMENTS

Supervisory Responsibilities:   IRB   and HRPP   Program

Number of Direct Reports:   0 -2

Minimum Education:   Bachelor's degree in a related field (e.g., research administration, healthcare, life sciences).

Degree:   Bachelor's

License/Certification Required:   None

Minimum Work Experience: Minimum 3-5 years of progressively responsible experience in IRB or human research protection administration, research compliance, healthcare regulatory compliance, quality or patient safety, accreditation, clinical research administration, legal/compliance operations, or another highly regulated healthcare or research environment involving   substantially transferable   responsibilities. Relevant experience should   demonstrate   proficiency   in regulatory interpretation, policy and procedure administration, committee or governance support, compliance monitoring, auditing, investigation, or management of complex regulatory workflows.

Location:   Primarily remote work is supported. Onsite presence is   required   for IRB or investigator meetings, internal or external audits/inspections, monitoring visits, in-person training, institutional leadership activities, and other operational needs requiring physical presence.

Preferred Degree:   Master's degree in a relevant discipline.

Preferred Certifications:   Certified IRB Professional (CIP) credential.

Preferred Experience: Direct experience with IRB/HRPP administration, human subjects research regulations, FDA-regulated research, Central/External IRBs, reliance agreements, multi-site research, or electronic IRB systems. Experience in an academic healthcare or pediatric research environment is preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

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Demonstrated ability to interpret and operationalize complex regulatory requirements; manage governance or committee processes; develop and   maintain   policies and procedures;   maintain   auditable regulatory records;   identify   and escalate compliance concerns; and coordinate complex work across multiple stakeholders.

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Advanced working knowledge of 45 CFR Part 46, including Subparts B, C, and D when applicable; 21 CFR Parts 50 and 56 for FDA-regulated research; and the HIPAA Privacy Rule as applicable to research.

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Ability to distinguish administrative/HRPP responsibilities from regulatory determinations reserved to the IRB, IRB Chair, or designated IRB members.

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Working knowledge of IRB composition, quorum, voting, conflict-of-interest, meeting, recordkeeping, and reporting requirements.

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Knowledge of single-IRB/CIRB reliance arrangements and the division of responsibilities between the Reviewing IRB and   relying   institution.

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Demonstrated ability to manage regulatory deadlines and records with a high degree of accuracy and detail.

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Excellent communication, writing,   critical-thinking , and regulatory interpretation skills.

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Experience reviewing research protocols and regulatory submissions for completeness and routing.

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Ability to communicate complex regulatory concepts clearly to investigators, IRB members, leaders, and institutional partners.

DUTIES AND RESPONSIBILITIES

Leadership & Program Oversight

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Provide operational leadership for the IRB/HRPP administrative program and   maintain   processes sufficient to support the IRB's federally required review, documentation, recordkeeping, communication, and oversight functions.

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Serve as the institution's primary administrative resource on IRB operations and human-subject protection requirements under OHRP and FDA regulations and applicable institutional policies.

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Maintain clear delegation pathways so that regulatory determinations are made by the convened IRB, IRB Chair, or appropriately designated IRB member when   required .

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Coordinate regulatory inspection, audit, and   accreditation   readiness for the IRB/HRPP and ensure   timely   production of required records.

IRB Membership, Registration, Quorum & Committee Administration

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Maintain the official IRB roster and documentation of member names, qualifications, experience, representative capacity, employment/affiliation status, and other information required by applicable regulations and IRB registration processes.

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Coordinate appointments, orientation, training, and use of alternate members; monitor membership composition to support compliance with regulatory requirements for diversity, scientific/nonscientific representation, and unaffiliated membership.

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Maintain IRB registration information and coordinate   timely   updates/renewals with OHRP and institutional leadership, as applicable.

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Prepare meeting agendas and review materials; assign reviewers in coordination with the IRB Chair; distribute materials with sufficient time for member review.

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Establish and document quorum before and throughout convened meetings, including   appropriate management   of recusals and conflicts of interest;   immediately   alert the Chair when quorum is lost and ensure no vote occurs without required quorum.

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Prepare and   maintain   minutes in sufficient detail to document attendance; actions taken; vote counts, including members voting for, against, or abstaining; the basis for requiring changes or disapproving research; and a written summary of controverted issues and their resolution.

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Communicate   IRB findings and actions promptly and accurately to investigators and the institution, consistent with the IRB's determinations.

Submission Intake, Review Workflow & Regulatory Routing

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Manage administrative intake and pre-review of   initial   submissions, continuing reviews when   required , modifications/amendments, closures, reportable events, and other submissions for completeness and   appropriate review   pathway.

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Coordinate   convened   and expedited review workflows. Ensure expedited reviews are performed only by the IRB   Chair   or one or more experienced IRB members   designated   by the Chair   in accordance with   applicable regulations.

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Track approval periods and   continuing-review   requirements when continuing review is   required ; provide advance notice to investigators and prevent administrative lapses from being treated as continued IRB approval.

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Ensure proposed changes in approved research are routed for IRB review and approval before implementation, except when necessary to   eliminate   apparent   immediate hazards to subjects, and route such exceptions for prompt IRB review.

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Support the IRB's application of the criteria for approval at 45 CFR 46.111 and, when applicable, 21 CFR 56.111 by ensuring reviewers receive complete materials and required information.

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Coordinate   additional   protections and   required   documentation for research involving vulnerable populations, including pregnant women/fetuses/neonates, prisoners, and children, when applicable.

IRB Records & Regulatory Documentation

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Maintain IRB records required by 45 CFR 46.115 and, when applicable, 21 CFR 56.115, including research proposals and reviewed scientific evaluations, approved consent documents, progress reports, reports of injuries/adverse events as applicable, correspondence, membership records, minutes, written procedures, and statements of significant new findings provided to subjects.

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Ensure IRB records are   retained   for the applic