Lead CRA for Multi-Site Clinical Trials

Fortrea; Kuala Lumpur; On-site; MYR 150,000 - 230,000; Full time

Job summary

Fortrea in Kuala Lumpur is seeking a Lead Clinical Research Associate to oversee site monitoring for multiple clinical studies in accordance with ICH GCP and Fortrea SOPs.

You will conduct pre-study and site initiation visits, manage data integrity, ensure SAE tracking, and collaborate with cross-functional teams while traveling up to 60% of the time. Fluency in English and local language required.

Qualifications

• University or college degree in a related allied health profession.
• Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
• Fluent in English and local office language.

Responsibilities

• Site monitoring for clinical trials including Pre-study, Initiation, Monitoring, and Close-out visits.
• Prepare and implement project plans related to Clinical Monitoring responsibilities.
• Ensure data integrity through source data verification and query resolution.
• Monitor SAE reporting and regulatory compliance, track IP inventory.
• Travel up to 60% to sites and attend investigators’ meetings as needed.

Skills

Clinical Monitoring

ICH GCP Knowledge

English Communication

SAE Reporting Process

Education

Bachelor's degree in Life Science

Tools

CTMS

eClinical systems

Job description

Fortrea in Kuala Lumpur is seeking a Lead Clinical Research Associate to oversee site monitoring for multiple clinical studies in accordance with ICH GCP and Fortrea SOPs.

You will conduct pre-study and site initiation visits, manage data integrity, ensure SAE tracking, and collaborate with cross-functional teams while traveling up to 60% of the time. Fluency in English and local language required.