外資系製薬会社

【Major Responsibilities】
• Monitors activities conducted by clinical investigative sites to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
• The Clinical Research Associate (CRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring that the company’s studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites.

【Essential Skills & Abilities】
• Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Experience in on-site monitoring of investigational drug or device trials is required.

【Education/Experience Required】
• Bachelor’s Degree required; medical/science/nursing background is preferred.