Bethesda, Maryland30+ days ago
Maintain and update files of all applicable regulatory documentation for IRB (including protocols, approvals, amendments, modifications, etc.) as well as internal study documents (logs, manual of procedures, etc.), and any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.). Oversee, prepare, and track regulatory lifecycle actions submitted to the Institutional Review Board (IRB) spanning from initial submissions to continuing review submissions, protocol amendments/modifications, reportable events, and closure reports, etc.