Iryna Rybalchenko, MD, PhD

Experience

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  V. Karazin Kharkiv National University

  Sept 2009 - May 2015

  • Worked closely with Principal Investigator and Clinical Research Associate on conduct of clinical trials• Performed recruitment of study participants, managed the informed consent process• Scheduled participant visits, performed procedures and assessments in accordance with the Protocol• Organized the collection and the shipment of biologic specimens • Maintained study binders and study inventory, ordered laboratory and other supplies• Entered the data into case-report forms and paper questionnaires (including recording of adverse events and concomitant medications, vital signs, physical examination etc.) • Monitored and followed-up the serious adverse events and reactions• Updated the study procedures/visits/inventory and training logs• Prepared amendments and submitted adverse event to Independent Ethic Committee• Participated in audits of State Expert Center and Sponsor Show less

  • Assistant Prof.,Internal Medicine Department

    Jan 2009 - May 2015

  • Investigator and Clinical Research Coordinator

    Sept 2009 - Jan 2013
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  PAREXEL

  May 2015 - Sept 2020

  Clinical Site Manager and Clinical Monitoring Associate

  • Performed all aspects of clinical monitoring tasks, including remote and on-site co-monitoring visits, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines ensuring patient safety and data integrity at all times• Acted as a first contact with assigned clinical sites, used judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites• Ensured timely resolution and closure of all site issues• Worked with team members to meet project goals and encourage the support of team member• Coordinated the payment process to investigator sites Show less

• 

  PPD

  Sept 2020 - now

  Remote Site Monitor (level II)

  • Performed all remote clinical monitoring tasks, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines ensuring patient safety and data integrity at all times• Acted as a remote contact with assigned clinical sites, used judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites• Ensured timely resolution and closure of all site issues• Worked with team members to meet project goals and encourage the support of team member• Coordinated the payment process to investigator sites Show less