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Regulatory Support Specialist, IRB Administrator
Assists and provides faculty with subject matter expertise, guidance, instructions and editing for creating and submitting initial IRB studies and initial follow-on submissions, including related regulatory documentation and reviews (e.g., HIPAA, FERPA, external IRB, JIT, FDA, other ancillary reviews). Advises and assists faculty with preparing and maintaining pre-submission through post-approval IRB-related regulatory files, including faculty self-audits, in accordance with applicable regulatory requirements and related policy and guidance. Provides 1-on-1 or group IRB systems training for faculty submission of studies for IRB review, including conducting and evaluating IRB systems training need
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