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 timelines and deliverables Act as Lead CRA on assigned studies, when applicable Qualifications & Experience Degree in Life Sciences, Nursing, Pharmacy, or related health discipline ( Equivalent experience may be considered) Minimum 2 years of independent Clinical Monitoring (CRA) experience Strong knowledge of ICH-GCP and clinical trial processes Understanding of Malaysian regulatory requirements Fluent in English (written and spoken) Experience using e.
Clinical systems (CTMS, EDC, eTMF) Preferred Phase I / Early Phase monitoring experience Strong communication, organization, and problem-solving skills Ability to work independently in a matrix environment Learn more about our EEO & Accommodations request here .