Unblinded CRA Position at Fortrea | Apply Now
A Fortrea CRA opportunity has emerged for aspiring Clinical Research Associates in Kuala Lumpur. Fortrea is seeking a qualified candidate for the Unblinded CRA 1 role, where they will be responsible for site monitoring and study management activities. Interested applicants should apply promptly.
- Position: Unblinded CRA 1
- Location: Kuala Lumpur, Malaysia
- Job Requisition ID: 265269
About Fortrea
Fortrea is a leading organization in the clinical research sector, dedicated to advancing healthcare through innovative research and development. With a commitment to ensuring patient safety and data integrity, Fortrea operates globally, providing essential services to support clinical trials and regulatory compliance.
Fortrea CRA Job Overview
As a Fortrea CRA, the selected candidate will be responsible for site monitoring and study management activities to ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and sponsor expectations. The CRA will serve as the primary contact for assigned sites while maintaining patient safety, data integrity, and investigational product accountability throughout the study.
Fortrea CRA Eligibility Criteria
- Bachelor’s Degree in Life Sciences, or a related healthcare discipline.
- Minimum 6 months of experience in clinical research, such as Clinical Research Coordinator (CRC), Research Nurse, IHCRA, Site Management, or similar roles.
- Basic understanding of ICH-GCP and local regulatory requirements.
- Fluent in English and Bahasa Malaysia, both written and spoken.
- Strong organizational, communication, and problem-solving skills.
- Ability to work effectively in a matrix and team-based environment.
Preferred Qualifications Include
- Previous site monitoring experience.
- Experience with investigational product accountability and study supplies.
- Experience with CTMS, EDC, or other clinical trial systems.
- Strong attention to detail and documentation skills.
- Interest in progressing into an independent CRA role.
Fortrea CRA 1 – Key Responsibilities
- Conduct monitoring visits including Site Initiation, Routine Monitoring, and Close-out Visits.
- Ensure protocol compliance, patient safety, and data quality throughout the study.
- Perform source document review, data verification, and query management.
- Review and maintain site regulatory documentation and study files.
- Manage investigational product (IP) accountability, storage, reconciliation, and study supplies.
- Track and follow up on safety reporting, protocol deviations, and site issues.
- Support feasibility assessments, study start-up activities, and site management tasks.
- Prepare monitoring reports and maintain inspection-ready documentation.
- Collaborate closely with investigators, site staff, vendors, and project teams to ensure study milestones are achieved.
Why Join Fortrea
Joining Fortrea offers a unique opportunity to contribute to impactful clinical research that enhances patient care. The organization values innovation, collaboration, and professional growth, making it an ideal environment for individuals passionate about advancing healthcare through research.
The Fortrea CRA 1 position in Kuala Lumpur is a significant step for qualified candidates looking to advance their careers in clinical research. Interested individuals are encouraged to apply before the deadline to ensure their consideration for this role.
