The COA supports the study team and completes the tasks required to enable the team to achieve the deliverables in the prescribed study timelines all throughout the clinical trial process. The CTA administers and maintains various logistical aspects of clinical trials in accordance with standard procedures and guidelines. The CTA is playing a key role to ensure transversal approach within the project management team by working on multiples studies with different Project Managers (PM).
A CTA who gained experience can evolve towards the position of Clinical Project Manager.
Duties and Responsibilities
- Organise study set-up activities in close collaboration with the PMs
- Contribute to the preparation of study protocol and informed consent forms and write any other clinical research related documents
- Assist with Ethics Committees and/or Competent Authorities submissions and filing necessary supportive documentation
- Assist with the sites selection (writing and collection of feasibility questionnaires, essential documents collection, …)
- Track site contracts approvals, invoices and payments (sites, vendors, grant providers, …)
- Participate in the coordination of Investigational Medicinal Product (IMP) supplies
- Ensure studies are carried out according to the study protocol, SOPs, and ICH GCP regulations and study specific manuals and procedures
- Report risks/issues that can affect the study and work to the study team to implement corrective actions
- Ensure appropriate filing of study documents in the trial master file
- Organise meetings (dates, agenda, minutes, ...)
- Organise study close down activities in close collaboration with other PMs
- Support the department in the development of documentation and process improvement.