Description
Fortrea is 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
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Ensure the protection of subjects and data integrity
- Verify informed consent procedures and protocol requirements are adhered to
- Perform source document review, source document verification, query generation, and resolution
- Confirm Site Regulatory documents and eTMF/Sponsor Documents are complete and current
- Ensure adherence to global quality control and CRA performance metrics
- Travel to study sites may be required
Qualifications:
- University or college degree in a related allied health profession
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Basic understanding of the clinical trial process
- Fluent in local office language and in English
- Minimum 2 years of Clinical Monitoring experience
Preferred Qualifications:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- Life Science or Nursing qualification
- Phase I monitoring experience
- Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications
Physical Demands/Work Environment:
- Must be able to sit at a computer for long periods of time
- Travel Requirement is 60% of the time (travelling to study sites)