As a Clinical Study Administrator, you will play a critical role within the clinical research team, providing administrative support and ensuring the timely and accurate management of essential study documents in compliance with regulations.
Key Responsibilities:
Building, maintaining, and managing the Trial Master File (v-TMF) and Clinical Trial Management System ((one)CTMS).
Creating and distributing regulatory binders and physical documents.
Supporting investigators and teams in resolving documentation and compliance-related issues.
Providing logistical support, including distribution of study materials and meeting organization.
Participating in process improvements related to (one)CTMS/v-TMF.
Assisting in the reporting and communication of clinical data.