Lead CRA - Ophthamology - Italy

Updated: May 06, 2024 06:23 PM GMT

Pharmiweb

Genoa, Metropolitan City of Genoa

Job Overview: As a Senior CRA specializing in ophthalmology, you will play a crucial role in the planning, implementation, monitoring, and management of clinical trials related to ophthalmic drugs, devices, or therapies. You will ensure that clinical trials are conducted in accordance with applicable regulatory requirements, protocols, and standard operating procedures.

Responsibilities
• Clinical Trial Monitoring:
• Conduct site initiation, routine monitoring, and close-out visits to ensure protocol compliance and data integrity.
• Perform source document verification, review of case report forms, and data validation.
• Monitor patient safety and report adverse events in adherence to regulatory guidelines.
• Site Management:
• Develop and maintain strong relationships with investigative sites, investigators, and study coordinators.
• Provide training to site staff on protocol requirements, study procedures, and Good Clinical Practice (GCP) guidelines.
• Protocol Adherence:
• Ensure... More Detail