Clinical Research Associate II
hace 3 semanas
Fortrea is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for conducting clinical trials according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans and Sponsor requirements.
Key Responsibilities:- Conduct site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP.
- 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 alongside applicable regulatory requirements.
- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
- 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.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- 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.
- A minimum of 2 years of Clinical Monitoring experience.
- Must be able to sit at a computer for long periods of time.
- Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
- 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.
- Travel Requirement is 60% of the time (traveling to study sites)
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