Job Overview:

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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