
Research Professional
4 days ago
Job Description:
This position is responsible for managing clinical studies and conducting site monitoring responsibilities in accordance with Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP.
- Verify study training records and ensure informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
- Conduct source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
- Ensure audit readiness at site level and guarantee the study Investigational Product inventory and accountability is accurate.
- Act in the project role of a Lead CRA as assigned.
Required Skills and Qualifications:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
- 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, both written and verbal.
Benefits:
The ideal candidate will possess excellent planning, organization, and problem-solving abilities and work efficiently and effectively in a matrix environment.
- Good attention to detail.
- Methodical approach to work.
- Good understanding of medical and clinical research terminology and clinical research processes.
Others:
Please note that travel requirement is 60% of the time (traveling to study sites).
To apply, please visit our website.
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