You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Requirements
Life science degree and / or equivalent experience
2 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research.
Availability for domestic travel including overnight stays, as required (international travel may be required for some senior level positions)
Excellent communication and organizational skills are essential. A team player.
Evidence of a client focused approach
Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
Fluency in English, Dutch
French will be a plus
oncology monitoring experience will be a plus
Tech Stack
Google Cloud Platform
Benefits
You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).