Clinical Operations Assistant (Clinical Trial Assistant)

Key Accountabilities

Project Initiation & Planning

• Contribute to site activation by:
  • Assisting/ with the site staff access to vendor systems
  • Access reconciliation quarterly
  • Following-up with sites to ensure staff training completion required by the study, including but not limited to vendor systems
  • Coordinating the Investigator’s Site File printing and shipment to sites as per the instructions received from the project team
  • Assisting with the material / equipment shipment to sites

Project maintenance

• Contribute to the project management by providing requested data to the clinical project leadership team (e.g. Principal investigator availability, etc…)
• Contribute to site maintenance and guarantee inspection readiness by:
  • Managing with quality the Trial Master File (TMF), which includes, but is not limited to: upload documents on time, assist wit...