As a Clinical Study Operations Trainee, you would help the Clinical Project Manager (CPM) with the following tasks:

• Checking and filing study documents
  • Review study documents to make sure they meet quality and compliance standards (ALCOA+) and upload/file them correctly in the electronic Trial Master File (eTMF).
• Monitoring eTMF quality
  • Perform regular spot checks to ensure study documents are complete, organized, and up to date, helping the CPM maintain inspection readiness.
• Maintaining study trackers
  • Update and manage study tracking tools and spreadsheets to ensure study progress and key activities are properly recorded.
• Managing vendor access
  • Help grant, update, and monitor system access for external vendors working on clinical studies.
• Supporting clinical site activities
  • Assist with operational tasks related to clinical trial sites as delegated by the CPM or Associate Clinical Project Manager (ACPM).
• Providing general project support
  • Carry out additional administrative or operational tasks needed to support the successful execution of clinical studies.

This role mainly involves ensuring clinical study documents are complete and compliant, maintaining study records and systems, supporting vendors and clinical sites, and assisting project managers with day-to-day study operations.