IRB Program Manager Full Time Days in Knoxville, Tennessee at Dolly Parton Children's Hospital

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

• 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.

• 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.

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

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

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

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

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

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

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

DUTIES AND RESPONSIBILITIES

Leadership & Program Oversight

• 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.

• 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.

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

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

IRB Membership, Registration, Quorum & Committee Administration

• 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.

• 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.

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

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

• 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.

• 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.

• 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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

• 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.

• Ensure IRB records are retained for the applicable regulatory retention period and remain accessible for inspection and copying by authorized federal agencies.

• Maintain authoritative documentation of IRB determinations, approval dates, expiration dates when applicable, conditions of approval, correspondence, and study status in the electronic IRB system.

• Maintain current written procedures describing required IRB operations and reporting processes and ensure practice is consistent with approved procedures.

Reportable Events, Noncompliance, Suspensions & Required External Reporting

• Administer intake, documentation, triage, and routing of unanticipated problems involving risks to subjects or others, allegations or findings of noncompliance, and other reportable events in accordance with written procedures.

• Coordinate fact gathering and administrative review for potential noncompliance while ensuring that regulatory determinations reserved to the IRB or other designated authority are not made administratively unless expressly authorized.

• Document and implement IRB-directed actions, corrective action plans, and follow-up requirements.

• Ensure prompt reporting, in accordance with written procedures, of unanticipated problems involving risks to subjects or others; serious or continuing noncompliance; and suspensions or terminations of IRB approval to appropriate institutional officials, applicable federal department or agency heads, OHRP, and FDA when required.

• Ensure suspension or termination communications include the IRB's reasons for the action and are distributed to required parties.

Policy, SOP & Written Procedure Governance

• Lead development, revision, approval routing, implementation, and scheduled review of IRB/HRPP policies, written procedures, SOPs, templates, forms, and guidance.

• Ensure written procedures address initial and continuing review; reporting findings/actions; review frequency and verification from sources other than the investigator when applicable; proposed changes; and required incident reporting.

• Monitor regulatory and guidance changes and update institutional procedures, training, forms, and workflows accordingly.

Central/External IRB Reliance & Cooperative Research

• Lead administrative processes for studies in which the institution relies on an external/Central IRB or serves as the Reviewing IRB, including reliance documentation and communication of assigned responsibilities.

• Maintain reliance agreements/IRB authorization documentation and records identifying the Reviewing IRB and the responsibilities retained by the relying institution.

• Ensure local institutional requirements retained under the reliance arrangement are completed and communicated to the Reviewing IRB, including local context, investigator/site information, conflicts, ancillary reviews, reportable events, and other responsibilities specified by the reliance agreement.

• Track Reviewing IRB approvals, modifications, continuing reviews when applicable, reportable events, suspensions/terminations, and study closure information relevant to the local site.

Informed Consent & Subject Protection Administration

• Ensure IRB-approved consent, parental permission, assent, and HIPAA authorization documents are version-controlled and made available to study teams as applicable.

• Verify that consent documents used for approved research correspond to the current IRB-approved version and contain required institutional/local information.

• Support documentation and communication of IRB-approved waivers or alterations of consent/parental permission and waivers of documentation; do not independently grant such waivers unless specifically authorized by regulation and institutional policy.

Quality Assurance, Monitoring & Continuous Improvement

• Maintain a risk-based IRB/HRPP quality assurance program to evaluate compliance with IRB determinations, institutional policy, reliance responsibilities, and required documentation.

• Conduct or coordinate audits of IRB administrative processes and approved studies; document findings and track corrective actions.

• Monitor timeliness, record completeness, meeting/minute quality, quorum documentation, reporting, reliance obligations, and other indicators of regulatory performance.

• Identify program-level improvement opportunities and implement process improvements without altering determinations reserved to the IRB.

Stakeholder Engagement, Education & Communication

• Serve as the primary institutional administrative point of contact for investigators and research personnel regarding IRB processes, submission requirements, and human-subject protection obligations.

• Provide orientation and ongoing education for IRB members regarding regulatory responsibilities, conflicts of interest, quorum, review pathways, documentation, and applicable vulnerable-population requirements.

• Provide education to investigators, research coordinators, residents, and institutional leaders regarding IRB requirements, reliance processes, reportable events, changes in approved research, and investigator responsibilities.

• Maintain collaborative relationships with external IRBs, partner institutions, the Institutional Official, Compliance, Legal, Privacy, Research Administration, Pharmacy, and other institutional stakeholders.

PHYSICAL REQUIREMENTS

Reasonable accommodation may be made for individuals with disabilities to perform the essential functions of this position.

• Light lifting, pushing, and pulling of 10-20 lbs may be required occasionally, with frequent movement of objects weighing less than 10 lbs. Frequent sitting and periodic walking, standing, squatting, bending, and reaching may be required. Keyboard/computer use and repetitive motions are routinely required.