Senior Clinical Research Coordinator
CurrentI currently work at IRCCS IRST's Coordinating and Data Center. I am also a CRA currently in training. Main activities:- protocols review for regulatory approval - documents review processing for regulatory approval- management of trials regulatory approval- preparation of sites feasibility- driving the conduct of the trial and tracking progress- trial centers start up- onsite staff training for site initiation visits- working with cross-functional teams (clinical monitors, dataanalysts…) for sites’ status and enrolment oversight- oversight of sites trial conduction in accordante to GCPs- conducting breefings with onsite staff- escalating issues promptly to ensure resolution- eCRF control for patient’s eligibility in clinical trials- generation of internal SOPs- generation of SOPs for the conduct of trials in the sites- archiving activity of trial documents in Trial Master File- Investigator Site Files generation for trial centers- Development Safety Update Report preparation