Clinical Project Manager

• Jul 2021 - Present

Clinical Research Manager

• Aug 2020 - Jun 2021

Senior Clinical Research Associate

• Sep 2017 - Aug 2020

All kinds of study monitoring activities, Local Study Responsible (Country Lead), new employees mentoring, QC. All kinds of study monitoring activities, Local Study Responsible (Country Lead), new employees mentoring, QC.

Senior CRA

• Apr 2015 - Sep 2017

All kinds of study monitoring activities. All kinds of study monitoring activities.

Senior CRA, Global Functional Resoursing, Quintiles providing services on behalf of Roche

• Oct 2014 - Mar 2015

Senior CRA Primary Accountabilities: • implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and GCP guidelines • Visit sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies • Provide regular clinical status information to team members and project management • Perform billable work in accordance with company policies, procedures, and Standard Operating Procedures • Work closely with other team members to ensure timely resolution of project and/or clinical issues and obtain directions from more senior clinical operations staff • Communications common site trends to Project manager or other project team members • perform investigative site file reconciliation; request any new or updated site-related essential and non-essential documents and review them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, GCP guidelines, project Standard Operational Procedures (SOPs), and sponsor requirements • Perform source document verification, retrieve Case Report Forms (CRFs), and perform query resolution in a timely manner and oversee drug accountability and safety at investigative sites • Ensure Serious Adverse Event (SAE) reporting according to project specifications • Respond to requests from investigative sites in a timely fashion • Serve as a resource for and interact with other functional areas to resolve site issues and facilitate project timelines • Participation on feasibility assessments • Support EC submissions and follow this process to approval, support the CA/Health authority

Senior Clinical Research Associate

• Aug 2013 - Sep 2014

All kinds of study monitoring activities. All kinds of study monitoring activities.

Senior Clinical Research Associate

• Nov 2011 - Aug 2013

All kinds of study monitoring activities.Indication: MS Protocol: A randomized, double-blinded, comparator-controlled clinical phase III studies in rheumatoid arthritis.Responsible for 5 sites, more than 35 patients in RussiaIndication: Psoriasis, study is in feasibility phase.Protocol: A randomised, double blind, double dummy, active comparator and placebo controlled confirmative non-inferiority trial phase III study in dermatology.Indication: VomitingProtocol: A randomized, double-blinded, comparator-controlled clinical phase II study in anesthesiology.Responsible for 5 sites, more than 50 patients in Russia

Clinical Research Associate (Worldwide Clinical Trials outsorcing staff)

• Dec 2010 - Nov 2011

All kinds of study monitoring activities.Indication: Urology (2 studies)Protocol: A randomized, double-blinded, comparator-controlled clinical phase III studies in overactive bladder.Responsible for 11 sites, more than 40 patients in RussiaIndication: MS Protocol: A randomized, double-blinded, comparator-controlled clinical phase III studies in rheumatoid arthritis.Responsible for 6 sites, more than 40 patients in Russia All kinds of study monitoring activities.Indication: Urology (2 studies)Protocol: A randomized, double-blinded, comparator-controlled clinical phase III studies in overactive bladder.Responsible for 11 sites, more than 40 patients in RussiaIndication: MS Protocol: A randomized, double-blinded, comparator-controlled clinical phase III studies in rheumatoid arthritis.Responsible for 6 sites, more than 40 patients in Russia

Clinical Research Associate II

• Oct 2009 - Dec 2010

All kinds of study monitoring activities.Indication: Vascular surgery/traumatologyProtocol: A randomized, open-label, comparator-controlled clinical phase III study in deep venous thrombosis resulting from fracture of legs.Responsible for 9 sites, more than 60 patients in RussiaIndication: UrologyProtocol: A randomized, open-label, comparator-controlled clinical phase III study in benign prostatic hyperplasia.Responsible for 4 sites, 20 patients in RussiaIndication: RheumatologyProtocol: A randomized, double-blinded, placebo-controlled clinical phase III study in Rheumatoid arthritis.Responsible for 7 sites, 26 patients in Russia

Clinical Research Associate

• Jun 2008 - Oct 2009

All kinds of study monitoring activities.Indication: OncologyProtocol: An open-label clinical phase IV studies in lung and mammar cancer.Responsible for 18 sites, more than 70 patients in Russia All kinds of study monitoring activities.Indication: OncologyProtocol: An open-label clinical phase IV studies in lung and mammar cancer.Responsible for 18 sites, more than 70 patients in Russia