Description
We are seeking a Clinical Research Associate to manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
Responsibilities:
- Conduct site management and monitoring responsibilities for clinical trials
- Verify study training records and ensure site regulatory documents are complete and current
- Safeguard data integrity through source document review and verification
- Ensure the protection of subjects and adherence to regulatory requirements
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Travel to study sites and perform on-site monitoring activities
- Work closely with the study team to ensure study deliverables are met
Requirements:
- University or college degree in a related allied health profession (e.g., nursing licensure)
- 2+ years of Clinical Monitoring experience
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Fluent in local office language and English
Preferred Qualifications:
- Thorough working knowledge of 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 computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications