Institutional Review Board Manager

Memorial Healthcare System seeks an Institutional Review Board Manager to lead IRB operations and ensure ethical, compliant human subjects research. This role oversees protocol submission and review workflows, coordinates IRB meetings, and maintains rigorous documentation. The manager interprets and applies FDA, OHRP, and HIPAA regulations, develops and updates IRB policies, and delivers training for investigators and staff. Working in a collaborative, mission-driven environment, this leader partners with research administration, compliance, and clinical teams to support innovative, patient-centered research that advances community health.

Responsibilities

• Oversee daily operations of the Institutional Review Board (IRB) ensuring compliant, timely review of human subjects research.
• Coordinate submission, review, approval, and continuing review of research protocols in alignment with federal and state regulations.
• Develop, update, and enforce IRB policies, SOPs, and best practices to support ethical research conduct.
• Provide guidance and training to investigators, research staff, and IRB members on regulations and institutional requirements.
• Monitor regulatory changes (FDA, OHRP, HIPAA) and implement process improvements to maintain accreditation-ready standards.
• Lead IRB meetings, prepare agendas and minutes, and ensure appropriate documentation and record retention.
• Collaborate with compliance, legal, and research administration to address complex or high risk protocols.
• Track IRB metrics, prepare reports, and present findings to leadership to support performance and quality improvement.

Required Skills

• IRB management
• Human subjects research regulations
• FDA and OHRP compliance
• HIPAA for research
• Research ethics
• Protocol review and oversight
• Policy and SOP development
• Regulatory documentation and reporting
• Audit and quality assurance in research
• Training and education for investigators
• GCP (Good Clinical Practice) knowledge
• Electronic IRB systems (e.g., IRBNet, i
• RIS)
• Risk assessment in clinical research
• Meeting facilitation and minutes
• Stakeholder communication