Clinical Trial Assistant
The Clinical Trial Assistant (CTA) works on clinical trials by assisting the Project Manager (PM) with the conduct of the assigned clinical trial(s) (administration, coordination, archiving). The CTA may assist with organizing the team meetings and will also help with the development of template documents to be used within the department as well as with the logistics of the departmental meetings.
The CTA assists the PM 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 PM
- 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
The CTA may assist COL with:
- The organisation of the clinical team meetings (agenda, meeting minutes, follow-up on action items)
The CTA helps the Head of Clinical Operations with:
- The development of template documents to be used within the Department
- The organization of the departmental meetings (agenda, meeting minutes, follow-up on action items)
- Requires knowledge of Good Clinical Practices.
- Speaks and writes Dutch and English fluently
- Knowledge of (e)TMF
- Proficient in software applications such as Outlook, Word, Excel and PowerPoint
- Experience with tools and systems for managing clinical trials such as MS project, trial progress and metric systems, eCRF, IXRS.
Education and experience:
- Bachelor’s degree or University degree – medical or para-medical or equivalent by experience
- Minimum of 3 years of experience in similar position within Clinical Operations
- Biotech experience is a plus
- An attractive salary in line with your experience and skills.
- Fringe benefits including a medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.
Evelien Van Eecke