Fortrea·12 days ago
12 days ago
CRA 2
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What you'll do
- 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
What they're looking for
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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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Company
Fortrea
Seoul, South Korea
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