TMF Assistant

TRIO is a unique, full-service clinical research organization (CRO) that leverages the strengths of our worldwide network of Investigators, academic leaders, patient advocates and our clinical research team to accelerate drug development.TRIO is looking for a TMF Assistant to join our Project Management team, reporting to the TMF Manager. While this position will be primarily home-based or hybrid, depending on the candidate's preference, going into the Edmonton, Alberta Office to complete certain tasks may be required. Responsibilities:This position is responsible for performing any/all of the following tasks and responsibilities, aswell as any other tasks deemed appropriate by the Supervisor:

• Processing study documentation per Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study-specific TMF Plans
• Performing quality review of documents submitted for filing into the electronic Trial Master File (eTMF) and liaising with the operational team to resolve any issue identified
• Uploading documents into the respective trial-specific eTMFs and assigning document metadata
• Maintaining compliance with TRIO requirements (quality, performance and training)
• If applicable, ensure paper trial documents are scanned and indexed into the (e)TMF
• Maintaining any eTMF oversight trackers if applicable
• Providing support to the TMF Manager as needed (e.g., running reports and metrics, preparing newsletters and meeting minutes)