Description
We are seeking a Clinical Research Monitor to join our FSP team in Portugal. As a Clinical Research Monitor, you will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans and Sponsor requirements.
Key responsibilities include:
- Conducting site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits
- Ensuring the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements
- Safeguarding data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines
- Confirming Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial
- Ensuring audit readiness at site level
To qualify for this role, you will need:
- 2 years minimum of experience as an independent monitor with centres in Portugal, specifically in oncology studies
- 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
- Fluent in local office language (Portuguese) and in English, both written and verbal
At Fortrea, you'll have the opportunity to contribute to meaningful clinical research, work alongside industry-leading experts, and help bring innovative therapies to patients worldwide.