Clinical Trial Associate (MNC)

Location: Petaling Jaya, Selangor

Job Descriptions:

• Conduct site qualification, initiation, monitoring (remote/interim), and closeout visits for pediatric and adult nutrition Phase 1–4 studies in compliance with protocols, GCP, ICH, and company SOPs.
• Set up and manage study sites in Veeva Vault CTMS; prepare, collect, update, and maintain essential study documents.
• Support vendor qualification and onboarding, and maintain good relationships with new and existing study-specific vendors.
• Conduct all clinical site activities per the monitoring plan, study timelines, and company objectives.
• Oversee and support clinical investigative sites across multiple protocols, motivating site staff to meet study objectives and recruitment goals.
• Ensure data quality and timely data submission, including proper reporting and follow-up of all safety events.
• Ensure the safety and protection of study participants in accordance with the monitoring plan, company SOPs, ICH guidelines, and applicable country regulations.
• Manage essential documents and EDPs, including collection, review, uploading, and sign-off in Veeva.
• Perform product accountability: verify on-site product inventory and identify discrepancies.
• Coordinate study product movement between depot and sites to ensure accurate tracking and adequate supply.
• Manage study materials, equipment, and device supplies to support smooth study execution.
• Prepare and submit IRB/IEC applications to obtain ethical approval.
• Train site personnel on the study protocol and regulatory requirements, in collaboration with project team members.
• Escalate major or unresolved site issues to the Clinical Project Manager as needed.
• Support Quality Assurance audits and ensure inspection readiness at assigned sites.
• Document monitoring activities accurately and submit clear, timely monitoring and administrative reports.
• Build effective, collaborative relationships with investigators, coordinators, and internal teams through regular communication.

Job Requirements:

• Bachelor’s degree, preferably in a Clinical Science, Nutrition, Nursing, or in Healthcare/ Life Science
• At least 1–2 years of experience in clinical research monitoring.
• Experience with site/project management and on-site monitoring of investigational products such as drugs, medical foods, or baby formulas.
• Solid understanding of ICH/GCP requirements and relevant local regulatory guidelines
• Experience in a compliance-driven environment is an advantage.
• Ability to work independently with minimal supervision.
• Willingness and ability to travel for planned and ad hoc site visits monthly.
• Strong English skills (reading, writing, speaking, and comprehension).
• Effective communication, problem-solving, organization, and time-management skills.

Others Information:

For those who have what it takes, please send in resume to: Recruitment Consultant: Wei Li Email: weili@brightprospect.com.my