A Clinical Trial Assistant (CTA) will manage administrative tasks throughout the life stages of a clinical trial, supporting the QF Local Study Team with the submission, collecting, listing, maintaining, tracking and updating (as corresponds) of trial related documentation; being a relevant liaison with other parties of the clinical study (Health Authorities, research sites, CRAs and Sponsor, when applicable).
At least, 1 year at similar position.
- Supporting, the Local Study Team collecting and tracking the documents and data required for regulatory submissions (contracts, financial agreements, patient informed consent forms, insurance certificates).
- Performing study submission to Health authorities, initial, amendments, notifications, etc.
- Maintaining and updating of the Trial Master File and preparation for relevant QC checks when applicable
- Tracking site budget related matters, including processing invoices, tracking payments and for scheduling meetings, updating Excel trackers, coordinating the translation of site documents.
- Train CTA trainees, if applicable.
Education and skills required:
- Postgraduate studies or course of Clinical Trial Assistant (or equivalent), ongoing or finished.
- Good command of written English.
- Excellent organizational and prioritization skills.
- Knowledge of Microsoft Office programs.
- Attention to detail and excellent oral and written communication skills.