Job Summary Coordinates all activities related to the Institutional Review Board and assures compliance with IRB guidelines and FDA regulations. In accordance with (45 CFR 46.101-409) the IRB Coordinator facilitates initial and continuing review of research protocols in compliance with policy, and state and federal regulations. Maintains all IRB documentation including all IRB applications, correspondence, continuing review requests, protocol deviations, and information required from the Principal Investigator. Audits compliance of policies and documentation requirements for the involvement of human participants in research. The IRB Coordinator has primary responsibility for the daily management of the IRB Office operations, processes, and activities in support of the Research Program. The IRB Coordinator also provides strong leadership in regulatory interpretation and implementation of all applicable regulations including but not limited to Department of Health and Human Services (DHHS) regulations: 45 CFR 46, and Food and Drug Administration (FDA) regulations: Title 21 Code of Federal Regulations. This includes initial determinations regarding expedited, exempt, or full board review, as well as human subject risk determinations. Supervises the Regulatory Project Assistant.
Monitors and analyzes current and new regulations affecting human subject protections and research privacy requirements, State and Federal agencies. Develops and implements policy and procedures accordingly
Independently coordinates/prepares monthly IRB committee meetings by developing agendas, minutes and review material for IRB members. Assembles IRB packets. Assigns reviewers. Attends meeting and transcribes minutes. Composes correspondence within time frame established by the Department of Health and Human Services (DHHS) and the FDA.
Reviews and revises IRB policy and procedures to maintain national accreditation.
Educates all IRB personnel, Principal Investigators, Study Coordinators, and staff as necessary.
Audits clinical research studies to assure compliance with federal regulations. Reports non-compliance to Research Compliance Administrator (RCA) and Research Integrity Officer (RIO).
Supervises maintenance of database of clinical trials. Retrieves data, compiles reports, and analyzes data.
Maintains all research records/IRB records according to guidelines established by the Department of Health and Human Services, the Food and Drug Administration and Scottsdale Healthcare Policies (organization/filing/ and maintenance of study files). Acts as a liaison between the IRB and Federal authorities when required.
Develops, maintains, and reviews IRB budget.
Internal Number: 2018-14066
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