European Correspondent - Hungary
Involvement in the entire process of running clinical trials since 2010: country feasibility, submission to the regulatory authorities and the ethics committee, site selection, initiation, regular monitoring and site close out visits. Experience from running, phase II-IV clinical trials in Hungary on various therapeutic fields (biological therapies, oncology, urology, neurology, medical device). Extensive experience with remote/risk based monitoring.
Nurse with 10 years of experience providing quality care to a wide variety of patients, focused on patient safety and well-being.
Start-up activities (including Feasibility/Site selection, Contract and budget negotiation, Regulatory/Ethics & Hospital submission)
On-site monitoring, Source data verification and site management (including site initiation, monitoring, co-monitoring, QC visit and close-out activities)
Pharmacovigilance activities (performing Serious Adverse Event Reconciliation activities, quality review and assurance, submitting reports to regulatory authorities )
Professional Trainings (eg. Regulatory, ICH/GCP, Monitoring)