General Responsibilities / Tasks :

• Monitoring of international clinical trials on phases I to IV.
• Conduct monitoring of clinical studies.
• Ensure the monitoring and scientific, technical and regulatory quality of international studies.
• Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administrated to the subjects / patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately re( labelled), imported and released / returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Contribute to the administrative missions required to set up and monitor clinical studies.
• Carry out monitoring and co-monitoring visits with local CRAs to ensure the quality of the data collected, source documents and archiving of investigative documents.
• Interpret the information collected by the various stakeholders in the study and contribute to the implementation of corrective or preventive actions if necessary.
• Be in contact with the study investigators.
• Revise the study sites if necessary.
• Prepare the sites and contribute to the audits and inspections.
• Write visit reports in English.
• Ensure the traceability of the deviations encountered according to a CAPA procedure.