Our client is a global biotechnology company located in the south of Brussels.
Studies are mainly in the field of oncology.
At least 1 day per week in the office is required.
The CRA is responsible for the proper conduct of the study according to protocol, ICH-GCP and all applicable requirements
- Feasibility studies, SIV, MV, COV: preparation, conduct and reporting
- Contract negotiations
- Submissions EC
- Involvement in safety reporting requirements
- Build and maintain good collaboration with site staff
- Supervise collection and filing of essential documents
- Provide sufficient site training
- Identify issues, and make and document the necessary corrective and preventive actions
- At least 2-3 years experience as CRA
- Preferably experience in oncology and phase I studies
- Medical/scientific academic degree or suitable experience
- Good verbal and written communication (Dutch, French and English)
- Good organizational and planning skills