Connection profile

gtsioumas

About: Acting as Project Manager in Phase 4 clinical studies. In particular: • Participating in the procedures of studies preparations through the active contribution to the development of Protocols, Informed Consent Form (ICF) and Case Report Form (CRF). • Communicating (either in person or by phone/online) with the Investigators/Research Teams who are planning to participate in each study and evaluating them. • Preparing files for studies submission to Ethical committees, Board of Directors of hospitals and financial management bodies. • Estimating clinical study budget of each site (preparation of the respective contracts) and of the total cost of the study. • Contributing to the Investigators’ meeting (through presentations and trainings). • Preparing, performing and reporting site visits such as initiation, monitoring and close out. • Monitoring sites for formality of patient enrollment procedures, follow-up visits, schedules and support them with Investigator/research team retraining – where required. • Monitoring, reporting and follow-up of adverse events, serious adverse events. • Ensuring that the study is conducted in accordance with the principles of Good Clinical Practice (GCP). • Settling of sites payments. • Communication and contact person between Sponsor and Investigator. Therapeutic Areas: Urology, Rheumatology, Neurology (CNS), Cardiovascular System (CVS)