Project involvement will be in an administrative role.
• Provides administrative support to the Clinical Operations function including set-up, maintenance and reconciliation of the Trial Master File (including RDMS) for studies on an as needed basis.
• The position entails work under general supervision for routine tasks and with detailed instructions on new assignments.
• Tracking and preparing study-specific information utilizing databases (GILDA, DataVision), spreadsheets, and other tools.
• Distributes updated study related documents (i.e. Investigative Brochures, package inserts) to study teams and internal departments as requested by the CTMA or CTM.
• Under close supervision reviews and participates in the quality assurance of data or documents including and not limited to GILDA and DataVision.
• Arranges meeting logistics.
• Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks).