Clinical Research Associate

Clinical Research Associate

OPIS

France

The Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.

Key Responsibilities

• Identify, assess, and initiate investigational sites;
• Conduct feasibility, pre-study, initiation, monitoring, and close-out visits;
• Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements;
• Perform source data verification and ensure data accuracy and completeness;
• Monitor patient recruitment and support sites in meeting targets;
• Ensure proper reporting of adverse events and protocol deviations;
• Manage investigational product handling, storage, and accountability;
• Maintain study documentation (TMF/eTMF, Investigator Files);
• Write monitoring reports and follow-up communications;
• Collaborate with project teams, sponsors, and site staff;
• Support audits/inspections and mentor junior CRAs.

Requirements

• Degree in a scientific field;
• Minimum 2 years’ CRA or clinical trial monitoring experience;
• Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes;
• Good English and Microsoft Office skills;
• Strong organizational, communication, and problem-solving abilities;
• Ability to work independently and in a team.