CRA II
Hybrid · Osaka, Osaka, Japan or Tokyo, Tokyo, Japan
Job Summary
CRA II performs site qualification, initiation, monitoring, and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. They verify informed consent, conduct source document review and data entry into CRFs, manage IP inventory and ISF/TMF reconciliation, support recruitment and retention, and collaborate with sponsor teams to achieve study objectives. The role requires a Bachelor’s degree or RN in a related field (or equivalent) and strong knowledge of GCP/ICH guidelines, with willingness to travel up to 75% and excellent communication and interpersonal skills.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
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