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 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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