Unblinded CRA 1

FTMYR Fortrea Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 60,000 - 85,000; Full time

Job summary

Fortrea Malaysia Sdn Bhd is seeking an CRA I to monitor sites and manage studies in alignment with ICH-GCP and regulatory requirements. You will be the primary contact for assigned sites, ensuring patient safety, data integrity, and IP accountability throughout the study.

Responsibilities include site initiation, routine monitoring, close-out visits, data verification, regulatory document reviews, and collaboration with investigators and project teams to achieve study milestones.

Qualifications

• Bachelor’s degree in a life sciences or healthcare field is required.
• Minimum 6 months of clinical research experience or related role.
• Basic understanding of ICH-GCP and local regulatory requirements.
• Fluent in English and Bahasa Malaysia, written and spoken.

Responsibilities

• Conduct site monitoring visits including initiation, routine, and close-out visits.
• Ensure protocol compliance, patient safety and data quality throughout the study.
• Perform source data verification, data checks, and query management.
• Review and maintain site regulatory documents and study files.
• Manage investigational product accountability, storage, reconciliation, and supplies.
• Track safety reporting, protocol deviations, and site issues.
• Support feasibility, start-up activities, and site management tasks.
• Prepare monitoring reports and maintain inspection-ready documentation.
• Collaborate with investigators, site staff, vendors, and project teams to meet milestones.

Skills

Site Monitoring

ICH-GCP Knowledge

Regulatory Compliance

Data Integrity

Communication

Bahasa Malaysia

English

Education

Bachelor's Degree in Life Sciences / Nursing / Pharmacy or related healthcare discipline

Tools

CTMS

EDC

IP Tracking Systems

Job description

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.

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.