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.
