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.
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 re...