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TMF Quality Specialist II
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Full-time
- The TMF Quality Specialist II (QS) will be responsible for the status of the TMF for all assigned clients.
- The TMF Quality Specialist II will be responsible for maintaining the quality of client Trial Master File integrity and assist in conducting internal and external audits of TMF contents.
- Plan and coordinate the management of the Trial Master File (TMF) and associated processes, including system and tool development, and business processes documentation
- Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and reviewed for quality on an ongoing basis
- Quality assurance check for each active study site for all regulatory documents, including: IRB Renewal, IRB Protocol Approval, Informed Consent Review, Signature of Co-Investigator, IRB Membership list, Lab Normal, CAP, CLIA, 1572 Form, Agreements, PI CVs
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