Experienced Clinical Trial Assistant
Several clients are looking for (experienced) Clinical Trial Assistants. Clients are CROs, pharmaceutical companies, … and located in different regions (e.g. Brussels region, Antwerp region).
The CTA is supporting a wide range of clinical studies. The CTA is an essential member of the clinical study conduct team. The incumbent will provide operational project support and is responsible for in-house or on-site activities as well as for compliance with processes required to initiate, maintain, support and close out the clinical trials managed by the department.
- Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials.
- Act as relationship manager with 3rd party vendors or with support groups such as ancillary supplies management.
- Create Essential Documents Repository.
- Assemble and track availability of all essential documentation required for study conduct.
- Provide professional presentation of study materials for investigator/vendor or country operations meetings.
- Safety reporting tracking.
- Liaise with sites and in house departments to ensure appropriate regulatory follow-up.
- Organization and documentation (minutes) of project team meetings
- Operational and project support activities, including, but not limited to:
- archiving and/or accountability for completeness of Trial Master File
- update, maintain and monitor CTMS (Clinical Trial Management system) to allow accurate project management, regulatory reporting and clinical grants payments
- follow-up/check final accountability of IMP and return or destruction as appropriate
- review study budgets/clinical trial agreements for consistency with study protocol
- updating of clinical and study planning databases
- Understanding and knowledge of study protocols and study working documents
- Interpersonal skills and ability to work in a team environment
- Advanced organization and planning skills
- Advanced communication skills (written and verbal) in local languages (Dutch and French) and English
- Advanced computer skills: e.g. professional using of MS Office programs for daily business
- Good understanding of the clinical research processes
- Understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations
- Education & Experience bachelor degree (e.g. medical assistant, or paramedical education) or relevant work experience in clinical research field
- Preferably a mature person with experience in a similar environment