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Clinical Research Associate II
hace 1 mes
We are seeking a highly motivated and experienced Clinical Research Associate II to join our team. The successful candidate will be responsible for conducting site monitoring responsibilities for clinical trials, preparing and implementing project plans, and ensuring the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to.
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.
- 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.
Requirements:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- A minimum of 2 years of Clinical Monitoring experience.
Working Conditions:
- 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).