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.
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
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
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.
Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com
