Clinical Research Associate II - FSP Team - Portugal
Fortrea · Oeiras
Main Responsibilities:
- Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
- Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
- 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.
- Ensures audit readiness at site level.
Qualifications (Minimum Required):
- 2 years minimum of experience as independent monitor with centers in Portugal, specifically in oncology studies.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Fluent in local office language and in English, both written and verbal.
If you're looking to grow your career within a global organization while working in a collaborative FSP environment, we'd love to hear from you. 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.
Apply today and join Fortrea's FSP team in Portugal, where your expertise can make a real difference in advancing healthcare!
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