COVANCE has an exciting opportunity for a Belgium based CRA.
It is essential that the successful candidate speaks fluent Dutch French and English.
We will consider full time OR 4 days/week.
This is a home-based position but some travel into the Brussels office would be expected on occasion.
Employed permanently by Covance you will be fully dedicated to one sponsor working in multiple therapeutic areas (Cardiology, Neurology, Rare Diseases) with a special focus on Oncology.
National travel within Belgium will be expected.
This opportunity sits within our FSP business model - a very attractive environment with great potential for career development.
Ideally we are looking for someone with monitoring experience but we will consider a junior (CRAI level) who is is looking to develop, as long as you already have some exposure to monitoring clinical trials.
Outsourced to our Client (a top ten pharmaceutical company) 100% of the time, you will be well supported by a dedicated Covance line manager as well as by the Client project teams.
Our Client has a very people orientated culture and a highly supportive environment in which you can regularly meet with managers face to face rather than working in a virtual world! There is also a buddy system and you would be very well looked after and guided.
Your primary focus will be the monitoring of investigational sites within Belgium.
- Site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and cooperation with Covance legal department with statements of agreements
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)Experience:
Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Excellent understanding of Serious Adverse Event (SAE) reporting
Ability to resolve project-related problems and prioritize workload for self and team
You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
Fluent in Dutch, French and English
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