Ekaterina Sello

Experience

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  Pharmacy ООО"Фармос-альфа"

  Oct 2012 - Apr 2013

  Pharmacist

  Dispensing drugs to patients, instructing them on how to use medication, possible side effects and storage, ordering new drug, maintaining pharmaceutical stock.

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  Www.free-lance.ru

  May 2013 - Jan 2014

  French/Russian Translator

  Translation from French to Russian of articles, videos, making a copy of the translated text

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  Volunteer project “Foreign press”

  Jul 2013 - Dec 2013

  Spanish/Russian Translator

  Translation from Spanish to Russian of articles, videos, making a copy of the translated text.

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  FNP Clinical LLC

  Apr 2015 - Oct 2016

  Performing site selection, qualification, site initiation, monitoring and close-out visits, management of sites during start up period, management of study progress, preparation of confidentiality agreements, contracts with sites and Principal Investigators, preparation of documents and submission to LEC, writing of Investigator’s Brochure. Communication with potential Principal Investigators, writing of Investigator’s Brochure, preparation of confidentiality agreements, contracts with sites and investigators.

  • Clinical Research Associate

    Jan 2016 - Oct 2016

  • Clinical Trial Assistant

    Apr 2015 - Dec 2015
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  IBC Generium

  Nov 2016 - Sept 2018

  Clinical Research Associate

  Performing site qualification, initiation, monitoring and close-out visits, management of study progress. Preparation of documents, communication with LEC. Organization of IP, lab kits shipments (communication with vendors, documents preparation and collection), preparation of payment documents. Documents preparation for inspection and audits.

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  MSD

  Sept 2018 - Mar 2020

  Clinical Resarch Associate II

  Working for MSD under contract with Covance. Site qualification, initiation, monitoring visits. Site management: communication with sites during contract preparation, LEC submission organization, performing of site trainings. Organization of IP, lab kits shipment. Communication with vendors, documents collection and uploading to eTMF.

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  IQVIA

  May 2020 - Jan 2023

  Clinical Research Associate II

  Site qualification, initiation, monitoring, close-out visits. Site management: communication with sites, vendors, payment group, managements of challenging situations due to the pandemic. Documents collecting for eTMF. Site preparation and assistance during Sponsor audit (no major or critical findings).

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  Benerix

  Sept 2023 - now

  Senior Clinical Research Associate