The CTA is responsible for providing support (administrative, logistic and document management) in the preparation and execution of all trial related activities within agreed timelines. The CTA should ensure complete trial documentation in accordance with the Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
We are looking for several CTAs who will be working at the clients’ offices, in combination with home office.
- To support the Clinical Research Associate(s) (CRA) and Project Manager(s) (PM).
- To ensure that the trial is documented in compliance with GCP and with all applicable regulatory requirements.
- To work according to the applicable quality management system of the client.
- To support the CRA(s) and PM(s) with all aspects of administration to ensure smooth conduct of the trial.
- To set up the Trial Master File (TMF) and Investigator Site File (ISF).
- To assist with the preparation and collection of essential clinical trial documents.
- To act as TMF owner and maintain all required essential documents in the TMF, including periodic review of files for completeness, preparation for internal/external audits, final reconciliation and archival.
- To coordinate ordering and tracking of trial materials and shipment of supplies to sites and monitor study supply levels.
- To coordinate document translation.
- To track, process and release payments to sites in collaboration with the trial team and finance department.
- To attend project team meetings and generate meeting minutes.
- To perform the submissions to Ethical Committees and Regulatory Authorities: initial submissions, notifications, amendments and safety information amongst other.
- To assist the CRA(s) in preparing, conducting and reporting site selection, initiation, monitoring and close-out visits.
- To work, when possible, in a pro-active /anticipating manner to avoid problems from occurring.
Bachelor or Master degree
Preferably at least 1 year experience in (international) clinical research
Fluent in English, Dutch and French; another European language is an asset
Microsoft Office (Outlook, Word, Excel, PowerPoint), internet; experience with eTMF (e.g., Veeva Vault); any experience with CTMS, eCRF systems is an advantage
Excellent knowledge of ICH-GCP and all applicable regulatory requirements
- Communicative: oral as well as in writing
- Team player
- Accurate and well organized
- Detail oriented
- Working independently