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
You have very good knowledge of Dutch and excellent knowledge of English
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
Clinical experience as well as eTMF experience is a plus
Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials would be even better!
Relevant experience in the Clinical Research field would be awesome!!
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.