1mo ago

Unblinded CRA 1

Malaysia·Kuala Lumpurmid

HealthcareClinical Researcher

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Quick Summary

Key Responsibilities

Conduct monitoring visits including Site Initiation, Routine Monitoring, and Close-out Visits. Ensure protocol compliance, patient safety, and data quality throughout the study.

Requirements Summary

Conduct monitoring visits including Site Initiation, Routine Monitoring, and Close-out Visits. Ensure protocol compliance, patient safety, and data quality throughout the study.

Technical Tools

HealthcareClinical Researcher

As an CRA I, you will be responsible for site monitoring and study management activities to ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and sponsor expectations. You will serve as the primary contact for assigned sites while maintaining patient safety, data integrity, and investigational product accountability throughout the study.

Responsibilities

~1 min read

→Conduct monitoring visits including Site Initiation, Routine Monitoring, and Close-out Visits.
→Ensure protocol compliance, patient safety, and data quality throughout the study.
→Perform source document review, data verification, and query management.
→Review and maintain site regulatory documentation and study files.
→Manage investigational product (IP) accountability, storage, reconciliation, and study supplies.
→Track and follow up on safety reporting, protocol deviations, and site issues.
→Support feasibility assessments, study start-up activities, and site management tasks.
→Prepare monitoring reports and maintain inspection-ready documentation.
→Collaborate closely with investigators, site staff, vendors, and project teams to ensure study milestones are achieved.

Requirements

~1 min read

Bachelor's Degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline.
Minimum 6 months of experience in clinical research, such as Clinical Research Coordinator (CRC), Research Nurse, IHCRA, Site Management, or similar roles.
Basic understanding of ICH-GCP and local regulatory requirements.
Fluent in English and Bahasa Malaysia, both written and spoken.
Strong organizational, communication, and problem-solving skills.
Ability to work effectively in a matrix and team-based environment.