Institutional Review Board (IRB) Coordinator

Essential Duties and Responsibilities

• Coordinate all administrative activities of the Institutional Review Board.
• Manage IRB submissions, protocol reviews, amendments, continuing reviews, closures, and reportable events.
• Prepare agenda materials and support documentation for IRB meetings.
• Attend IRB meetings and serve as recording secretary.
• Document meeting minutes and maintain official records of IRB deliberations and actions.
• Communicate IRB determinations, stipulations, and approval notifications to investigators and study teams.
• Maintain compliance with applicable federal regulations, including: Department of Health and Human Services (HHS) regulations (45 CFR 46), FDA regulations governing clinical investigations, HIPAA Privacy Rule requirements, Good Clinical Practice (GCP) standards, Institutional policies and procedures.
• Review informed consent documents for required regulatory elements.
• Ensure appropriate documentation of IRB actions and retention of regulatory records.
• Monitor protocol expiration dates and ensure timely continuing review activities when required.
• Track and manage reportable events, protocol deviations, unanticipated problems, and non-compliance matters.
• Serve as a resource to investigators and research teams regarding IRB requirements, submission processes, and regulatory expectations.
• Provide education and guidance regarding human subjects protection and ethical research practices.
• Affiliate with development and delivery of educational programs related to human subjects research protections.
• Assist investigators with preparation and submission of protocols and required documentation.
• Facilitate communication among investigators, sponsors, research personnel, and IRB members.

Education and Training

• Coordinate onboarding and ongoing education for IRB members.
• Affiliate with development and delivery of educational programs related to human subjects research protections.
• Monitor and track required research-related training and certifications.
• Promote awareness of regulatory updates and institutional policy changes impacting research activities.

Quality Improvement and Program Development

• Participate in audits and regulatory inspections.
• Affiliate with development, implementation, and revision of IRB policies, procedures, and forms.
• Conduct periodic quality assurance reviews of IRB records and processes.
• Support initiatives to improve efficiency, effectiveness, and compliance within the human research protection program.

Data Management and Reporting

• Maintain accurate regulatory databases and tracking systems (e.g. IRBNET, CITI, etc).
• Generate reports related to IRB activities, protocol status, approval metrics, and compliance monitoring.
• Prepare information and reports for leadership, committees, auditors, and regulatory agencies as requested.