Clinical Trial Coordinator
fortrea
Unblinded CRA 1
fortrea· FTMYR Fortrea Malaysia Sdn Bhd
About this role
Job Overview:
As an CRA I, you will be responsible for site monitoring and study management activities to ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and sponsor expectations. You will serve as the primary contact for assigned sites while maintaining patient safety, data integrity, and investigational product accountability throughout the study.
Summary of 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.
Qualifications (Minimum Required):
- Bachelor's Degree in Life Sciences, Nursing, Pharmacy, 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.
Learn more about our EEO & Accommodations request here.
Frequently Asked Questions
Is the salary disclosed for the Unblinded CRA 1 position at fortrea?
The salary for this Unblinded CRA 1 role at fortrea is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Unblinded CRA 1 position at fortrea located?
This Unblinded CRA 1 role at fortrea is based in Kuala Lumpur. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Unblinded CRA 1 role at fortrea full-time or part-time?
This is listed as a Full time position. It is posted as a Unblinded CRA 1 role in the FTMYR Fortrea Malaysia Sdn Bhd department at fortrea.
Which team or department does the Unblinded CRA 1 at fortrea belong to?
This Unblinded CRA 1 position is part of the FTMYR Fortrea Malaysia Sdn Bhd department at fortrea. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Unblinded CRA 1 position at fortrea?
Click the "Apply Now" button on this page. You will be redirected to fortrea's official application portal hosted on workday where you can submit your application directly.
When was the Unblinded CRA 1 job at fortrea posted?
This Unblinded CRA 1 position at fortrea was posted on Sep 10, 2026. Apply as soon as possible — early applications are often reviewed first.
Unblinded CRA 1
fortrea
You'll be redirected to fortrea's official application page on Workday.