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 bachelor degree ‘Medical/Administrative assistant’ or equivalent by relevant experience
- Minimum of 3 years of experience in a similar position within Clinical Operations
- 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, full electric company car and charging card, 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.