CRA II - Sr. CRA I

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 re...