Responsible for the day to day operations and oversight of the Institutional Review Board. In conjunction with the Chairman, ensures hospital policies and procedures are maintained in compliance with the FDA, code of Federal Regulations, and Good Clinical Practice. Monitors the overall safety of the research patient, including HIPAA.
Coordinates with Principal Investigators and study coordinators seeking to submit a study through the IRB review process. Drafts correspondence that conveys deliberations and actions of IRB, including but not limited to, approvals, deferrals, and disapprovals of research activities involving human subjects, in accordance with FDA regulations. Ensures compliance of Serious Adverse Event reporting in order to maintain research patient safety. Follows up with all Serious Adverse Events to ensure the total well being of the research patient, including HIPAA. Actions may include escalation to appropriate Chair, disciplinary letter to approriate party, sanctioning, and, closure of study. Prepares for FDA Inspections of Investigator Sites. Audit IRB files under the auspices of the Chairman to ensure Good Clinical Practice throughout the Healthcare System to be inspection ready at all times. Maintains institutional enrollment and compliance in applicable federal registries including the Federal Wide Assurance (FWA) and IRB Registration (IORG). Provides consultation, assistance, and dissemination of information regarding the review process to the IRB members and research community. Processes all internal and external correspondence regarding the IRB and prioritizes it for disposition by the IRB Chairman. Provides administration of IRB committee in accordance with applicable laws and regulations under the supervision of the Chairman and applicable manager. Support local CRAs with site visits. Maintains database of all studies, including archival. Seeks to optimize electronic resources of the Department. Prepares the electronic Policy and Procedures for approval by the IRB and maintains the electronic database to ensure continuity, education, and compliance with applicable federal regulation. Meets all required competencies for department, unit and/or hospital. Responsible for performing all other duties as assigned. Special Projects Invoices and collects applicable IRB fees according to schedule.
Work requires knowledge of theories, principles, and concepts acquired through the completion of a Bachelor's degree in a closely related field and two to three years of previous work related experience. Advanced computer proficiency/Microsoft Office at a minimum. SOCRA certification preferred