Description
We are seeking a Clinical Research Associate to join our Core Team in Seoul. The successful candidate will have at least 2 years of experience in clinical monitoring.
Job Summary: As a Clinical Research Associate, you will be responsible for site management and monitoring of clinical trials according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
Key Responsibilities:
- Conduct site monitoring visits, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits
- Verify study training records and ensure site regulatory documents are complete and current
- Ensure data integrity through source document review, source document verification, and query generation
- Protect subjects by verifying informed consent procedures and protocol requirements are adhered to
- Prepare and implement project plans related to clinical monitoring responsibilities
- Travel to study sites, which may include international travel, and prepare trip reports
Requirements:
- University or college degree in a related field (e.g., nursing licensure)
- At least 2 years of clinical monitoring experience
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Fluent in Korean and English, both written and verbal
- Ability to work independently with minimal supervision
Preferred Qualifications:
- Experience with Fortrea SOPs for site monitoring
- Additional years of experience in a related field (e.g., medical, clinical, pharmaceutical)
- Phase I monitoring experience
- Life Science or Nursing qualification
- Good attention to detail and methodical approach to work
Physical Demands/Work Environment:
- Must be able to sit at a computer for long periods
- May require travel to study sites (up to 60% of the time)
- Standard office and/or home working environment