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 Learn more about our EEO & Accommodations request here .