职责描述
Job Summary
The CTSS Intern will provide operational and administrative support to the Clinical Trial Site Service team under the guidance of experienced CTSS professionals. The role involves supporting trial documentation management, regulatory submission preparation, safety mailing activities, and general administrative tasks. In addition, the intern will assist the team in leveraging AI tools and automation solutions to support document handling, data processing, and workflow efficiency, contributing to continuous process improvement and digital enablement within the CTSS function.
Key Responsibilities
Support the setup, maintenance, and organization of Trial Master Files (TMF) / eTMF at country and site level.
Assist in filing and archiving trial documents to ensure completeness, accuracy.
Support preparation of regulatory submission materials including Ethics Committee (EC) submission packages and Safety Mailing materials.
Assist in preparation and organization of Safety Mailing reports and tracking of safety documentation.
Support application of AI tools and automation for document handling, data consolidation, and efficiency improvement.
Assist in basic data processing, reporting, and preparation of trackers or summaries.
Provide general administrative support and perform other tasks as assigned by the CTSS team.