会社概要
外資系製薬会社
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仕事内容
【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.
応募資格
【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.