Clinical Research Associate II - FSP Team - Portugal
PharmaCROBiotechClinical ResearchRegulatory Affairsgcpinform
Job description
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! Learn more about our EEO & Accommodations request here .
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