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 ResponsibilitiesPerform 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
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)
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.
Skills Required
- Degree in Life Sciences, Nursing, Pharmacy, or related health discipline
- Minimum 2 years of independent Clinical Monitoring experience
- Strong knowledge of ICH-GCP and clinical trial processes
- Fluent in English (written and spoken)
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
