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 monitoring responsibilities for clinical trials, 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 that informed consent procedures and protocol requirements are adhered to
- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current
- Guarantee that the study Investigational Product inventory and accountability is accurate
- Ensure adherence to global quality control and CRA performance metrics
- Ensure audit readiness at site level
- Act as a Lead CRA as assigned
General On-Site Monitoring Responsibilities:
- Ensure study staff have received proper materials and instructions to safely enter subjects into the study
- Perform eligibility review and verify screening, informed consent procedures, and protocol requirements
- Monitor data for missing or implausible data
- Ensure study data completeness, accuracy, consistency, and compliance
- Identify deficiencies, deviations, and discrepancies, and initiate corrective action
- Perform monitoring tasks efficiently and manage travel expenses economically
- Travel to study sites, prepare and submit trip reports, and perform eCRF review and source data verification
Qualifications:
- University or college degree, or certification 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
Experience:
- Minimum 2 years of Clinical Monitoring experience
- Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines
- Ability to work with minimal supervision
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
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
- Travel Requirement is 60% of the time