Location
kuala lumpur
Job Type
Full-time
Posted
June 10, 2026
Job Description
Role Summary
The Clinical Research Associate (CRA) is responsible for site monitoring and management activities for clinical trials conducted in Malaysia, ensuring compliance with ICH‑GCP, Fortrea SOPs, local regulatory requirements, and Sponsor expectations.
Key Responsibilities
- Perform site monitoring visits including Site Initiation, Routine Monitoring, and Close‑Out Visits.
- Ensure subject safety, protocol compliance, and informed consent adherence.
- Conduct source document review, SDV, eCRF review, and query management.
- Ensure data integrity, accuracy, and regulatory compliance.
- Manage site regulatory documents, eTMF, and study files.
- Verify Investigational Product (IP) storage, accountability, and reconciliation.
- Track and follow up on Serious Adverse Events (SAEs).
- Maintain audit and inspection readiness at site level.
- Collaborate with study teams to meet project...