Processes essential documents for inclusion in the Trial Master File (TMF), and manages study trial documentation from the completion of the regulatory start-up packet to study closure. Commonly performs a QC of post start-up documentation to ensure documentation is compliant with ICH/GCP, regulatory, and sponsor requirements. Collaborates with the project team to maintain an up-to-date and complete TMF through-out the life of the clinical trial.
Core Responsibilities
Performs the ...
INC Research - 30+ days ago
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