Experienced Clinical Research Associate, Tokyo
Core
Conduct qualification, initiation, monitoring, and closeout visits at research sites to ensure compliance with protocols and regulations for clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biopharma and medical device studies
Domain
Clinical Research / Biopharmaceuticals / Medical Devices
Required skills
Clinical trial monitoring, regulatory compliance (GCP/J-GCP), site qualification, source data verification, adverse event reporting, patient recruitment assessment, risk-based monitoring, Microsoft Office proficiency
Preferred skills
Oncology or rare disease therapeutic area experience, Phase 1 First-in-Human study experience, leadership potential
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Conduct on-site and virtual monitoring visits; verify investigator qualifications and resources; review medical records and source documentation; assess patient recruitment and retention; report adverse events and protocol deviations; complete monitoring reports and follow-up letters.
Seniority
Experienced (minimum 1 year)
