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):
- 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.
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.
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