CRA I - Romania

Key Responsibilities

• Conduct site monitoring activities, including pre‑study, initiation, routine monitoring and close‑out visits.
• Ensure patient safety, data integrity and protocol compliance through source data review and oversight of informed consent.
• Manage study sites in line with project plans, ensuring audit readiness and timely issue resolution.
• Act as the main point of contact for sites, vendors and internal teams, including oversight of supplies and documentation.
• Prepare accurate monitoring reports and support study delivery through efficient planning and travel management.

Requirements

• Degree in life sciences, nursing or a related health discipline, or equivalent relevant experience.
• At least 6 months’ experience in clinical research (e.g. site management, study coordination, in‑house CRA).
• Basic knowledge of ICH‑GCP, regulatory guidelines and the clinical trial process.
• Strong organisational skills, attention to detail and ability to work effectively in a matrix environment.
• Fluency in English and Romanian; willingness to travel as required and a valid driving licence.