Clinical Research Associate II
hace 3 semanas
Job Summary:
Clinical Research Associate II - Site Management Specialist
Responsibilities:
- Manage clinical studies at sites according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
- 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 throughout the duration of the trial.
- Guarantee that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
- Ensure adherence to global quality control and CRA performance metrics.
- Ensure audit readiness at site level.
- Act in the project role of a Lead CRA as assigned.
Requirements:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
- Thorough understanding of ICH GCP Guidelines and understanding of 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.
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