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