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:
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General administrative assistance to the Clinical Research Team (CRA’s, CPM’s, Medical department, …)
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Preparing, updating, follow-up of electronic filing of clinical trial related documents
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Preparing of study binders for site use
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Assisting in the preparation/submission of submission packages to the Ethics Committees/Institutional Review Board
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Correspondence with internal and external parties (mainly in English)
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Attending team meetings, writing meeting minutes and/or reports
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Arranging investigator meetings, general meetings
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Arranging international travel
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Entering, updating and tracking of records in the Clinical Trial Management System
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Handling of study supplies (incl. shipments, tracking, …)
Qualifications
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You have a bachelor degree ‘Medical/Administrative assistant’ or equivalent by relevant experience
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You have very good knowledge of Dutch and excellent knowledge of English
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You have good organisational skills
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You have a profound knowledge of Microsoft Office
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You are interested in using multiple databases
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You are a real team player
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You are precise and have a great eye for detail
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Clinical experience as well as eTMF experience is a plus
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Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials would be even better!
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Relevant experience in the Clinical Research field would be awesome!!
What we offer:
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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, …)
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Side activities will be organised regularly, to achieve a close collaboration within our team
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We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
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We contribute to a number of charities & support the research and / or the patients in our industry.