Roman Plotnikov Email and Phone Number

Eleven years in Clinical Studies (4,5 years in PRA), including 8 years team leader activities for clinical trials in endocrinology, oncology, gastroenterology, hematology, nephrology etc. Successful audits and FDA inspection. Besides regular monitoring, coordination of pulmonary laboratories wasperformed for several trials. Selection of new sites (including high enrolling) were performed for some trials. Contract negotiations with Institution to evolve potential sites. Sponsor's Face-to Face meetings, TC participation. Successful completion of CRA assessment test, completion of Oncology University training with high score assessment. Had substantial experience in using specific databases (EDC system, IVRS/IWRS systems, electronic data sharing applications, electronic time management system) and standard computer applications such as MS Word, MS Excel, MS PowerPoint, MS Project, MSOutlook. Undergone a number of trainings related to ICH GCP, monitoring activities, safety, pharmacovigilance etc.