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Unblinded CRA 1
Job Location:
Job Location:
Kuala Lumpur - Malaysia
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
11 September 2026 (4 days ago)
Posted:
Application Deadline:
9 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Overview:
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.
Summary of Responsibilities:
- 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.
Qualifications (Minimum Required):
- Bachelors 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.
Preferred Qualifications Include:
- Previous site monitoring experience.
- Experience with investigational product accountability and study supplies.
- Experience with CTMS EDC or other clinical trial systems.
- Strong attention to detail and documentation skills.
- Interest in progressing into an independent CRA role.
Learn more about our EEO & Accommodations request here.
