About this role

Set up, monitor and close investigational sites in accordance with the protocol
Perform on-site monitoring (7 to 8 trips per month), ensuring data quality
Verify consistency of source data and ensure compliance with GCP/ICH
Manage study logistics (traceability of treatments, supplies/equipment, investigator site file)
Identify and resolve on-site issues (recruitment, protocol deviations, SAEs)
Write visit reports and follow up on corrective actions
Maintain clear communication between the sponsor and investigational sites

Master’s degree in a scientific field (MSc), PhD or Pharmacist degree
1 to 3 years of monitoring experience in interventional research, gained in a CRO or pharmaceutical company (required)
Required experience with Phase II and Phase III studies
Proficiency with EDC systems and CTMS
Knowledge of French and European regulations
Oncology experience required
Rigour, autonomy, strong interpersonal skills and ability to adapt to frequent travel
Professional English (written and spoken) required

Consultant CRA, Junior Clinical Research Associate

Key skills