Elena KESSLER MD

Clinical Trials

Conducting site monitoring responsibilities, according to client/companys’ SOPs, ICH GCP and FDA guidelines, performing feasibility, Selection visits, Initiation, Routine Monitoring visits and Close-out Visits in Germany, Austria and Switzerland

Conducting site monitoring responsibilities, according to client/companys’ SOPs, ICH GCP and FDA guidelines, including feasibility, Pre-study qualification, Initiation, RMVs and Close-out Visits in Germany, Austria and Switzerland.

Overall leadership of a multicounty team of CRAs, coordination and support of all aspects of clinical monitoring & site management process in accordance w/ ICH GCP, FDA guidelines, local regulations & employer SOP

Medical and Safety Review of eCRF, patients data

Responsible for Medical and Safety studies results, Medical review of patients data (eCRF, Oracle), analysis and generation of medical and scientific reports