Clinical Research Associate

Medpace; Kuala Lumpur; On-site; MYR 90,000 - 150,000; Full time

Job summary

Medpace is seeking a Clinical Research Monitor to conduct qualification, initiation, monitoring, and closeout visits across research sites in Malaysia. You will verify investigator qualifications, ensure compliant data, and maintain regulatory oversight while communicating with site staff and ensuring patient safety.

The role requires 60-80% national travel, a health or life science degree, and 1.5–5 years of monitoring experience, with strong communication and MS Office skills.

Qualifications

• Bachelor’s degree in Health or Life Science related field preferred.
• At least 1.5 to 5 years of experience in clinical monitoring.
• Willing to travel approximately 60-80% nationally.
• Familiarity with Microsoft Office.
• Strong communication and presentation skills a plus.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff.
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
• Medical record and research source documentation verification against case report form data, ensuring good documentation practices and communicating deviations as per SOPs, GCP and regulatory requirements.
• Verification that the investigator is enrolling only eligible subjects.
• Regulatory document review.
• Medical device and/or investigational product/drug accountability and inventory.
• Verification and review of adverse events and related data to ensure accurate reporting per protocol.
• Assessing the site’s patient recruitment and retention and offering improvements.
• Completion of monitoring reports and follow-up letters with summaries and recommended actions.

Skills

Communication skills

Presentation skills

Education

Bachelor's degree in Health or Life Science

Tools

Microsoft Office

Job description

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications:

• Bachelor’s degree in Health or Life Science related field preferred;
• At least 1.5 to 5 years of experience in clinical monitoring;
• Willing to travel approximately 60-80% nationally;
• Familiarity with Microsoft® Office; and
• Strong communication and presentation skills a plus.