Job Overview:
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.
Skills 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 source data verification, regulatory documentation, and site management
- Fluency in Korean and English
- Ability to work independently and manage multiple priorities
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
