Clinical Research Associate (MNC Pharma)

Location: Petaling Jaya, Kuala Lumpur

Job Descriptions:

• Conduct site visits, and Phase 1-4 studies, including qualification, initiation, monitoring, and closeout, following protocols, regulatory guidelines, GCP, ICH, and SOPs.
• Set up study site management in Veeva Vault CTMS and collect and manage essential documents for assigned sites.
• Oversee the activities of clinical investigative sites across multiple protocols.
• Oversee site personnel activities to motivate and guide them in meeting study objectives.
• Ensure the quality and timely submission of data from study sites
• Collect and upload critical documents into SharePoint, maintaining Permanent Study Files for assigned sites throughout the trial, and prepare, review, submit, and obtain sign-off on Essential Documents Packages (EDP).
• Perform on-site product inventory counts and compare with site records to identify discrepancies.
• Prepare and submit IRB applications for ethical approval at study sites.
• Facilitate Quality Assurance Audits as required.
• Ensure regulatory inspection readiness at assigned clinical sites.
• Build & maintain professional relationships with study personnel, peers, and office-based staff.

Job Requirements:

• Bachelor’s Degree in clinical science, nutrition, or nursing, or equivalent
• At least 2-3 years of working experience in clinical research / on-site monitoring of investigation products or relevant experience preferred
• Applicant with knowledge of ICH/GCP Guidelines, and applicable local regulations is added advantage.
• Excellent site management and monitoring skills.
• Effective communication and problem-solving skills
• Proficient in computer skills

Others Information:

For those who have what it takes, please send in resume to:

Recruitment Consultant : Janice Lim
Email : janice@brightprospect.com.my