Entry-Level CRA: Monitoring & Study Coordination

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

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.