Tatiana Klementeva

Experience

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  Institute of General Pathology and Pathophysiology

  Jul 2013 - Oct 2015

  Junior research fellow
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  Quintiles

  Nov 2015 - Jan 2022

  Late Phase CRA

  - perform site start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.- administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.- manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.- create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.- provide assistance to less experienced clinical staff. Show less

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  IQVIA

  Feb 2022 - now

  Regulatory Affairs Specialist

  • Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;• Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;• Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;• May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;• May prepare and deliver regulatory training to IQVIA small groups or individuals;• Performs other tasks or assignments, as delegated by Regulatory management; Show less