About this role
Job Overview: As a CRA, you will manage and monitor clinical trial sites to ensure patient safety, data integrity, protocol compliance, and successful study delivery in accordance with ICH-GCP, local regulatory requirements, and sponsor expectations.
Key Responsibilities:
• Conduct site monitoring visits, including Site Initiation, Routine Monitoring, and Close-out Visits. • Ensure protocol compliance, patient safety, and data quality throughout the study. • Perform source data verification (SDV), source document review, and query management. • Review and maintain site regulatory documents and study files to ensure inspection readiness. • Manage investigational product accountability and study supplies. • Identify and escalate site risks, protocol deviations, and compliance issues. • Collaborate with investigators, site staff, and project teams to ensure study milestones are achieved. • Prepare monitoring reports and maintain study documentation in accordance with SOPs and regulatory requirements
Qualifications (Minimum Required):
• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. • Minimum 2 years of independent monitoring experience as a CRA. • Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring processes. • Experience with SDV, regulatory documentation, and site management. • Fluent in Korean and English. • Ability to work independently and manage multiple priorities.
Travel Requirement:
• Up to 60% travel within Korea
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