Clinical Research Associate II
hace 2 semanas
Fortrea is seeking a highly motivated and experienced Clinical Research Associate II (CRA II) to join our team. As a CRA II, you will be responsible for conducting site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP.
Key Responsibilities:- Conduct site monitoring responsibilities for clinical trials according to Fortrea's SOPs, ICH guidelines, and GCP.
- Prepares and implements project plans related to Clinical Monitoring responsibilities.
- Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
- Safeguards 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.
- Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
- Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
- Ensures adherence to global quality control and CRA performance metrics.
- Ensures audit readiness at site level.
- Acts 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.
- 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.
- Respiratory and/or Cardiology 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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