Compulsory internship at Production Line

Compulsory internship at Quality Control Laboratory

-Supporting Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team in the accurate updating and maintenance of clinical documents and systems, such as the Trial Master File (TMF), to monitor site compliance and performance within project deadlines.-Aiding the clinical team in tasks like preparing, handling, distributing, filing, and archiving clinical documents and reports in alignment with project specifications and standard operating procedures.-Assisting in periodically reviewing study files to ensure they are complete.-Assisting CRAs and RSU in preparing, handling, and distributing Clinical Trial Supplies and maintaining tracking information.-Playing a role in monitoring and managing Case Report Forms (CRFs), addressing queries, and overseeing the flow of clinical data.-Serving as the central point of contact for project-related communications, correspondence, and associated documentation for the clinical team.-Collaborating with the clinical team to manage the preparation, handling, distribution, filing, and archiving of clinical documents and reports in adherence to project scope and standard operating procedures.-Carrying out submissions to Ethics Committees and Ministries of Health (EC/MOH).