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.
Job Summary As a Clinical Research Associate, you will be responsible for site management and monitoring of clinical trials. This includes verifying study training records, conducting site initiation visits, routine monitoring, and close-out visits. You will ensure the protection of subjects, safeguard data integrity, and confirm site regulatory documents are complete and current.
Responsibilities
- Manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements
- Conduct site monitoring responsibilities, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Ensure the protection of subjects by verifying informed consent procedures and protocol requirements are adhered to
- Safeguard data integrity through 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, which may include air travel, and prepare accurate and timely trip reports
- Independently perform eCRF review, source data verification, query generation, and resolution
- Assist with administration of clinical research projects, recruiting investigators, collecting investigator documentation, and site management
- Update and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems
Qualifications
- University or college degree, or certification in a related allied health profession
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Thorough knowledge of monitoring procedures
- Basic understanding of the clinical trial process
- Fluent in local office language and in English, both written and verbal
- A minimum of 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
- Specific skills, systems, certifications, and/or licenses
- Good attention to detail, methodical approach to work, and good understanding of medical and clinical research terminology
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
- Risk of eye strain
- Will involve outside of normal office hours as required
- Travel Requirement is 60% of the time