Entry-Level Clinical Research Associate, Osaka
Core
Conduct on-site and virtual monitoring visits at clinical research sites to ensure protocol compliance, data accuracy, and regulatory adherence for drug and medical device development.
Role type
Entry-Level Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and medical device studies
Domain
Healthcare / Clinical Research / Biopharmaceuticals
Deliverable
client delivery
Required skills
Medical record verification, regulatory document review, adverse event reporting, site qualification, inventory management, risk-based monitoring, patient recruitment assessment, report writing
Preferred skills
Clinical research experience, advanced degrees, oncology/rare disease study experience
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits; Verify investigator qualifications and resources; Review medical records and source documentation against case report forms; Monitor adverse events and serious adverse events; Assess patient recruitment and retention; Complete monitoring reports and follow-up letters.
Seniority
Entry-Level, Training Program