Clinical Trial Assistant

The key purpose of the role is to assist the clinical Research team (CRA’s / CPM’s) in its day-to-day business. Working in a team environment, this position requires you are used to working close together with your team, your colleague CTAs as well as with other departments and stakeholders.

Main activities are:

• General administrative assistance to the Clinical Research Team (CRA’s, CPM’s, Medical department, …)
• Preparing, updating, follow-up of electronic filing of clinical trial related documents
• Preparing of study binders for site use
• Assisting in the preparation/submission of submission packages to the Ethics Committees/Institutional Review Board
• Correspondence with internal and external parties (mainly in English)
• Attending team meetings, writing meeting minutes and/or reports
• Arranging investigator meetings, general meetings
• Arranging international travel
• Entering, updating and tracking of records in the Clinical Trial Management System
• Handling of study supplies (incl. shipments, tracking, …)

Qualifications:

• You have a relevant bachelor or master degree or equivalent by experience
• 1-3 years of experience in a similar position within Clinical or Medical Administration
• You have excellent knowledge of English and one additional language (Dutch/French)
• Experience with trial progress and metric systems (eg CTMS, Interactive Response Technology (IRT), Interactive Voice/Web Response System (IXRS), and eTMF)
• Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials
• You have good organisational skills
• You have a profound knowledge of Microsoft Office
• You are interested in using multiple databases
• You are a real team player
• You are precise and have a great eye for detail

What we offer:

✓ We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included).

✓ We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …).

✓ Side activities will be organised regularly, to achieve a close collaboration within our team.

✓ We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.

✓ We contribute to a number of charities & support the research and / or the patients in our industry.