The Clinical Trial Assistant (CTA) works on clinical trials by assisting the study team with the conduct of the assigned clinical trials: administration, coordination, archiving.
The CTA assists with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs):
- Assists with signature collection, contracts, POs and insurance certificates in collaboration with team members
- Develops and adapts documents to trial specific requirements in collaboration with the trial team
- May assist with the preparation of trial reports for the trial team and keeping them up-to-date
- Assists with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings
- Assists the PM to ensure that the essential trial documents at sponsor level are properly filed and made ready for archiving.
- Provides input to the other departments outside Clinical Operations to ensure that the needed documents are filed within the (e)TMF.
- Assists in (electronic) Trial Master File review (TMF) to confirm completeness and follow-up of findings
- Assist with the organization of the clinical team meetings (agenda, meeting minutes, follow-up on action items)
- Support to development of template documents to be used within the department