Clinical Research Associate: Site & Study Manager

PSG GLOBAL; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

PSG GLOBAL is seeking a Clinical Research Associate in Kuala Lumpur to manage clinical studies from site selection through close-out in line with ICH-GCP and SOPs. You will monitor sites, train staff, ensure data quality, and manage study materials and budgets across trials.

The role requires a bachelor’s degree in a medical field, at least 3 years CRA experience, and strong knowledge of GCP and regulatory requirements, with proficiency in MS Office applications.

Qualifications

• Bachelor degree or above in Medical, Pharmacology or Biology related major.
• At least 3 years' CRA experience.
• Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures.
• Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsibilities

• Study site management from site selection to initiation and monitoring and close-out.
• Perform pre-study visit (SIV) to select eligible sites with adequate resources and experience.
• Prepare and conduct SIV to train site staff for study start and conduct.
• Ensure PI/study staff complies with safety reporting per protocol, SOP, ICH-GCP and GCP.
• Track study recruitment to meet targets across studies.
• Conduct monitoring visits per SDV plan and SOP; address issues and finalize reports.
• Coordinate timely delivery of study materials (drug, non-drug, equipment, CRFs) to sites.
• Assemble site EC submission dossiers and ensure submission to EC.
• Provide ongoing training on ICH-GCP and study requirements.
• Maintain essential documents and trial master files; archiving per protocol.
• Disseminate SAE information to sites and ensure timely SAE reporting.
• Finalize budget and obtain signed contracts prior to site initiation.
• Ensure Study Payment Schedule is executed and retain relevant receipts.
• Update and maintain study tools/systems promptly.

Skills

CRA experience

GCP knowledge

Microsoft Office

Education

Bachelor degree in Medical/Pharmacology/Biology

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

PSG GLOBAL is seeking a Clinical Research Associate in Kuala Lumpur to manage clinical studies from site selection through close-out in line with ICH-GCP and SOPs. You will monitor sites, train staff, ensure data quality, and manage study materials and budgets across trials.

The role requires a bachelor’s degree in a medical field, at least 3 years CRA experience, and strong knowledge of GCP and regulatory requirements, with proficiency in MS Office applications.