Unblinded CRA 1

Fortrea; Kuala Lumpur; On-site; MYR 60,000 - 100,000; Full time

Job summary

Fortrea in Malaysia is seeking a dedicated Clinical Research Associate (CRA) to monitor sites and manage study activities in line with ICH-GCP, regulatory requirements, and sponsor expectations. You will be the primary contact for assigned sites, ensuring patient safety, data integrity, and investigational product accountability throughout the study.

Responsibilities include monitoring visits, site regulatory documentation, IP accountability, safety reporting, and collaboration with

Qualifications

• Bachelor's Degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline.
• 6+ months of experience in clinical research or related roles.
• Fluent in English and Bahasa Malaysia, written and spoken.

Responsibilities

• Conduct site monitoring visits including Initiation, Routine Monitoring, and Close-out visits.
• Ensure protocol compliance, patient safety and data quality.
• Perform source data verification and query management.
• Maintain site regulatory documentation and study files.
• Manage investigational product accountability, storage and supplies.

Skills

English language

Bahasa Malaysia

Organizational skills

Communication skills

Problem-solving

Education

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

Tools

CTMS

EDC

Job description

Jora Malaysia will close on 16th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

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.

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