Clinical Trial Management Associate

Essential Functions:

• TMF: Set up and maintain the site level TMF/eTMF, coordinate on document collection, uploading into SharePoint (SP)/eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required.

• EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.

• Process protocol amendments; may include ICF updates.

• Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed.

• Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking.

• Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work.

• Administrative: Business and department office administration support if required.