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Clinical Research Associate
The Clinical Research Associate (CRA) has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study team(s) in NLBE. The CRA works in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centers in clinical studies per Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Senior CRA or Local Study Team Leader (LSTL).
Skills and personality
- University degree in related discipline, preferably in life science, or equivalent qualification.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations with main focus on Belgium.
- Good medical knowledge in relevant Therapeutic Areas.
- Good understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Ability to travel nationally (Belgium and Netherlands) and internationally as required.
- Valid driving license
- Languages: fluent Flemish/Dutch, French, English
- Knowledge on relevant regulations in the Netherlands
minimum 3 years
Higher Scientific Degree
Dutch, English, French
Submit your CV
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