Description of the PositionMain duties of the CRA is monitoring of clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and IRIS Standard Operating Procedures (SOPs).
Additional responsibilities may, amongst others, include:
- Inform and train investigator teams on the study project (with the help of the study PM), and get them organized.
- Organize investigator team meetings (in collaboration with the study PM and CTA).
- Ensure centre readiness for study start.
- Attend Monitors and Investigators meeting when organized.
- Assist Project Manager in the preparation of audits and the follow-up of audit findings.
- Liaise as required with study related CROs.
Demands of the PositionLanguage: English, Dutch
Experience as CRA (at least 2 years). Experience in related function eg study startup department or as in house CRA can be taken into account, but hands on experience in monitoring is required.
Preferable experience in Oncology and phase I.