Tatiana Meleshenko

- Identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. - Monitor sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP. - Primary responsibility for site management and performance, including documentation. - Site management activities included all in-house and on-site monitoring for all visit types.

- Main point of contact for the study, including any site queries. - Follow up with site recruitment status, action items following monitoring visits, ICH GCP essential documents, site staff training, lab sample management. - Investigator Site File / Trial Master File Reconciliation. - Support with safety reporting. - Mentoring of inexperienced in-house CRA.

• Translation and editing of medical literature, editorial project management (EPM): • Search, evaluation and selection of articles and guidelines for publishing in the World Medicine Standards journal, editing the translations of these guidelines. • Translation and editing of books, articles and promotion materials for WHO, The European Observatory on Health Systems and Policies, AIDS Foundation East-West, Baxter, Astellas, Genzyme and others.

Medical cybernetics