CRA II
Hybrid · Tokyo, Tokyo, Japan
Job Summary
CRA II performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate site performance and provides action plans; maintains knowledge of ICH/GCP guidelines and applicable regulations; verifies informed consent processes; protects subject confidentiality; assesses factors affecting subject safety and data integrity; conducts Source Document Review and CRF data verification; applies query resolution techniques remotely and on-site; supports IP inventory/reconciliation and ISF/TMF maintenance; ensures IP labeling/dispensing per protocol; coordinates site training and audit readiness; supports patient recruitment and retention; tracks observations and action items; travels as required (up to 75%); collaborates with sponsor teams and cross-functional members; may train junior staff and participate in investigator meetings; emphasizes data quality and regulatory compliance throughout the study lifecycle.
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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