Major Duties of CTA:
o Requests payments for study related cost
o Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner
o Attends appropriate training programs and project teleconferences as applicable.
o Maintains the study status tracking and provides analysis report to Project Manager.
o Assists Project Manager on study budget control by timely tracking and reporting of actual cost and forecast drafting.
o Coordinates Clinical Study Agreement approval to ensure site initiation on time.
o Supports and coordinates the clinical trial application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.
o Coordinates and applies for export/import license of, lab kits, equipments, and specimen, if applicable.
o Supports for preparation of site initiation packages (e.g. SMF)
o Organizes investigator meeting
o Supports and coordinates the clinical trial application for amendment and progress report to ethics committee and regulatory authority, if applicable, and obtain approval within required timeline.
o Maintains / develops local tracking spreadsheets for study-related documents, data, tasks and activities, as applicable.
o Assists CRA for the responsibility of tracking, distribution and filing of clinical trial documents/information (e.g. SUSAR, paper CRFs, DCFs ) with quality review for accuracy and completeness.
o Ensures along with the CRA the reconciliation of Trial Master File and the Site Master File
o Supports SM and CRA for final archive of study-related documents
o Ensures study payment completion.
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