Description
Fortrea is seeking a Clinical Research Associate to manage clinical studies according to Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
Responsibilities:
- Conduct site 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
- Safeguard data integrity through source document review and verification
- 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
- Fluency in local office language and English
- Minimum 2 years of Clinical Monitoring experience
Preferred Qualifications:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- Additional years of experience in a related field
- Phase I monitoring experience
- Life Science or Nursing qualification
Physical Demands/Work Environment:
- Must be able to sit at a computer for long periods
- Travel Requirement is 60% of the time