Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures. Serve as a communication hub for vendors and sites as well as for sponsor’s management team; establish project leadership; participate in Business Development client presentations and bid defenses as requested. Regulatory Documentation: assure compliance with regulatory requirements and SOPs; maintain current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan. Monitoring: site management, i.e. all types of site visits; assure compliance with protocol, recruitment plan, reporting requirements for AEs/ SAEs and protocol deviations, IP accountability, maintenance of site Regulatory Binder Data Handling: SDV according to contractual requirements; timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and Data Management Plan (DMP).

- Functioned as Lead CRA for Russia in global projects - Set up, coordinated and monitored multicenter international trials in Russia; identified potential investigative sites and performed feasibility tasks and qualification calls and visits; - Established proper communication between sponsor, project team and investigative sites to maintain adequate enrolment rate and achieve study goals/meet timelines/implement plans. - Managed team work, performed training and coaching of CRA team, delivered regular internal team calls for study status update and questions resolution, performed co-monitoring visits and ensured corrective actions implementation; coordinated audit preparation and response; - Interacted with internal work groups to evaluate needs, resources and timelines - Acted as a primary contact for clinical trial suppliers, central labs and vendors - Compiled submission letters to Russian Regulatory Authorities and applications for import/export permit - Compiled study progress reports to Russian Regulatory Authorities and sponsoring companies

- Responsible for all aspects of study site monitoring including selection, initiation, routine monitoring and close-out of clinical sites, maintenance of study files; communication with vendors; and other duties, as assigned - Ensured study staff was supplied with proper materials and instructions to safely enroll patients to the study - Ensured protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements - Ensured integrity of the data collected on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitored data for missing or implausible data. - Reviewed progress of projects and initiated appropriate actions to achieve target objectives - performed CRF review; query generation and resolution according to data review guidelines - Assisted with training, mentoring and development of new employees