About the position The IRB Program Manager is responsible for the end‑to-end supervision, coordination, and continual improvement of the IRB program, including committee administration, regulatory compliance activities, policy and procedure oversight, and feasibility review. This role serves as the institutional steward of human subjects’ protections, ensuring cohesive program operations, aligned regulatory practices, and consistent application of ethical standards across all human research activities.

Responsibilities

• Provide operational leadership for all components of the IRB program, including review workflows, communication with investigators, and compliance with federal and institutional guidelines.
• Serve as the institution’s primary resource on IRB operations, human subjects’ protections, and regulatory frameworks (OHRP, FDA, HIPAA).
• Create strong, collaborative relationships with research leadership from academic partner institutions, helping to coordinate research oversight, alignment of expectations, and shared standards for ethical research.
• Oversee all aspects of IRB committee management, including meeting agendas, prereview processes, minute accuracy, reviewer assignments, documentation quality, and post-meeting follow up.
• Ensure committee workflows operate smoothly, consistently, and in alignment with institutional priorities and regulatory requirements.
• Provide direct support to IRB Chairs and board members to ensure consistent interpretation and application of regulations and ethical principles.
• Lead ongoing oversight, development, revision, and maintenance of IRB policies, SOPs, templates, and guidance materials.
• Establish a structured and continuous review cycle to ensure all documents remain current with evolving federal regulations, accreditation standards, institutional requirements, and best practices.
• Coordinate with Legal, Compliance, and Research Administration to ensure institutional alignment and approval pathways for policy updates.
• Conduct and oversee feasibility assessments for proposed research, evaluating institutional resources, patient population, and operational readiness.
• Collaborate with investigators early in protocol development to promote studies that are ethically sound, feasible, and institutionally appropriate.
• Liaise with clinical operations, research administration, and other stakeholders to ensure coordinated preparation for study activation.
• Manage comprehensive review workflows for local IRB submissions, including initial and continuing review, amendments, reportable events, and noncompliance determinations.
• Lead processes for studies reviewed by Central IRBs, ensuring that all institutional responsibilities are met, documented, and communicated effectively.
• Lead the design, execution, and continuous refinement of the IRB’s auditing, monitoring, and quality assurance programs.
• Conduct internal audits of IRB processes and approved studies; ensure corrective actions are implemented, documented, and tracked.
• Identify program level improvement opportunities and lead efforts to optimize efficiency, consistency, and service quality within the IRB office.
• Serve as the primary institutional point of contact for investigators and research personnel regarding IRB expectations, processes, and regulatory requirements.
• Maintain collaborative relationships with external IRBs, partner academic institutions, and institutional leaders.
• Provide constructive feedback and targeted education to improve submission quality and regulatory compliance.
• Lead training efforts for investigators, research coordinators, and residents to promote effective and compliant IRB interactions.

Requirements

• Bachelor’s degree in a related field (e.g., research administration, healthcare, life sciences).
• Minimum 3–5 years of experience in IRB administration, human subjects’ protections, or research oversight.
• Strong knowledge of federal regulations governing human research (45 CFR 46; 21 CFR 50/56; HIPAA Privacy Rule).
• Demonstrated ability to manage multiple deadlines with a high degree of accuracy and detail.
• Excellent communication, writing, and critical thinking skills.
• Experience reviewing research protocols or regulatory submissions.
• Deep understanding of human subjects’ regulations and IRB operations.
• Works effectively with staff, investigators, and institutional partners.
• Ensures precision and consistency in reviews and documentation.
• Communicates complex regulatory concepts clearly to diverse audiences.
• Thrives in a growing and evolving research environment.

Nice-to-haves

• Master's degree preferred
• Certified IRB Professional (CIP) credential preferred
• Experience working with Central IRBs, reliance agreements, or multi-site research preferred.
• Experience in academic healthcare or pediatric research environments preferred.
• Familiarity with electronic IRB platforms preferred.