CRA 2

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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