Description
Fortrea is seeking a Clinical Research Associate to manage clinical studies according to their Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
Responsibilities:
- Manage clinical studies, including site management and monitoring responsibilities
- Conduct site monitoring visits, including pre-study, initiation, process monitoring, routine monitoring, and close-out visits
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Ensure subject protection by verifying informed consent procedures and protocol requirements
- 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, which may be required up to 60% of the time
Qualifications:
- University or college degree in a related allied health profession (e.g., nursing licensure)
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Basic understanding of the clinical trial process
- Fluent in local office language and English, both written and verbal
- 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 (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
- Must be able to use hands to finger, handle or touch objects, tools or controls
- Standard office and/or home working environment
- Clinical Research Unit and hospital environment (administrative only)
- Risk of eye strain
- Will involve outside of normal office hours as required by the role