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IRB Regulatory Affairs Administrator
Provides expertise in and works independently to administer IRB regulatory review of expedited and exempt research protocols. Determines whether full committee review of research is required. Leads targeted reviews and audits of human subjects research to address IRB-related concerns about compliance with federal and state regulations and internal guidelines. Develops and leads education programs for principal investigators, clinical research professionals and other research staff about Good Clinical Practices governing human subjects research as well as IRB requirements for research. Manages IRB review of human subjects protocols in biomedical, and social and behavioral sciences. Leads assessment of quality assurance and quality improvement studies to determine if they qualify as human
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