IRB Program Manager Full Time Days

BASIC PURPOSE OF THE JOB 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. REPORTS TO

• Director of Quality, Patient Safety, and Medical Affairs

JOB REQUIREMENTS Supervisory Responsibilities: IRB Program Number of Direct Reports: 0 Minimum Education: Bachelor's degree in a related field (e.g., research administration, healthcare, life sciences). Master's degree preferred Degree: Bachelor's License/Certification Required: Certified IRB Professional (CIP) credential preferred Minimum Work Experience: Minimum 3-5 years of experience in IRB administration, human subjects' protections, or research oversight. Location: Primarily remote work is supported. Onsite presence is required for: IRB or investigator meetings, internal or external audits, monitoring visits, in-person training or institutional leadership activities, other operational needs requiring physical presence. 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. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• 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.

DUTIES AND RESPONSIBILITIES

• Leadership & Program Oversight
• 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.
• IRB Committee Administration
• 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.
• Policy, SOP, and Guidance Document Governance
• 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.
• Feasibility Review & Research Readiness Coordination
• 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.
• IRB Operations & Central IRB (CIRB) Reliance
• 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.
• Quality, Compliance & Continuous Improvement
• Lead the design, execution, and continuous refinement of the IRB's auditing, monitoring, and quality assurance programs.
• Conduct internal audits of IRB processes an

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