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Administrative Assistant Clinical Research

IRB Specialist:
Immediate opening for a contract position to provide support for data collection and reporting of clinical trial data in accordance with protocols subject to FDA oversight; work independently with the COH Institutional Review Board (IRB), Clinical Research Support Regulatory Affairs staff, and the Office of General Counsel in consultation on regulatory compliance issues; use appropriate judgment in fulfilling regulatory compliance, quality assurance, and liaison activities;work independently in documenting procedures, preparing reports, distributing communications, and coordinating special regulatory projects.
This individual will prepare, track, and maintain all correspondence and regulatory documentation required by IRB, FDA, RACC, IACUC, IBC, OSBC, RUC and other institutional and federal research oversight committees.
Ensure compliance with ongoing reporting requirements including IRB and FDA initial protocol/IND submissions, annual reports, study amendment, safety reports, problem/noncompliance reports.
Assist in preparation and revision of protocols, consent forms, and other required documents for new and continuing studies.
Serve as the primary point of contact and resource to Investigators, study sponsors, and study team members for all general and protocol-specific regulatory requirements and communicates with Investigators and study teams concerning status of regulatory approvals and changes in protocols, consent forms, or other study documents.
Perform other responsibilities as assigned.
If you are available and interested in working with a leading healthcare provider with long term opportunities this may be the job for you.


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