1mo ago

CRA 2

HealthcareClinical Researcher

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Quick Summary

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.

Requirements Summary

Conduct site monitoring visits, including Site Initiation, Routine Monitoring, and Close-out Visits. Ensure protocol compliance, patient safety, and data quality throughout the study.

Technical Tools

HealthcareClinical Researcher

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.

Responsibilities

~1 min read

→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

Requirements

~1 min read

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.