Irina Reunova

Experience

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  INVITRO

  May 2016 - Feb 2018

  • Organized clinical trials of medical devices for in vitro diagnostics• Developed experimental schemes• Evaluated laboratory facilities for implementation of necessary tests• Negotiated with manufacturers about design and terms of clinical trials• Implemented statistical analysis of the study results• Compared characteristics of trial subjects and reference devices• Validated new tests • Communicated with various laboratory departments in the framework of trials• Wrote safety and efficiency reports of tested devices • Record-keeping of various projects Show less

  • Phisician/investigator

    Mar 2017 - Feb 2018

  • Clinical Research Assistant

    May 2016 - Mar 2017
• 

  Covance

  Feb 2018 - Sept 2021

  • Assist local project team members with administrative activities as required (e.g. payments to investigators, correspondence with Clients, preparation of status reports, and organization of investigators meetings)• Act as contact for project team and study sites• Ensure compliance with CRO and Client SOPs, GCP, local and global regulations for clinical conduct in all aspects of daily work• Assist with the management of study supplies and organize shipments• Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data• Perform EDC review, query generation and resolution against established data review guidelines, under direct supervision on CRO or Client data management systems, as assigned• Update, track and maintain study-specific trial management files, tools and systems• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities• TMF review and maintenance• Global project tasks support (EDC, IxRS and other systems access vendor requests, access trackers maintenance)• Feasibility process assistance (Investigators contact, CDA, study materials distribution, survey completion)• On-site CRA co-monitoring tasks during RMV and COV as required and according to training goals (source data verification, drug accountability, Study File Notebook review)• RMV confirmation and follow up correspondence preparation/distribution on behalf of CRA• Complex CRA assistance in internal site audit preparation • Perform other duties as assigned by management Show less

  • Clinical Research Associate II working under contract with MSD

    Jun 2021 - Sept 2021

  • Clinical Research Associate I working under contract with MSD

    Oct 2019 - Jun 2021

  • CRassist

    Feb 2018 - Oct 2019
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  MSD

  Sept 2021 - now

  • Sr.CRA/ eCRF SuperUser

    Jun 2023 - now

  • CRA

    Sept 2021 - now