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 eClinical 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
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