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Experiences

Current Experience

  • Quality Assurance Auditor Moscow, Russia
    Since March 2015

    Official duties: planning and conducting co-monitoring visits and audits (phase I to IV clinical studies in Russia for different therapeutic areas: pulmonology, oncology, rheumatology, ophthalmology, neurology, infectious diseases, healthy volunteers etc.). Vendor management: central laboratories and warehouses audits/ assessments. Implementation and improvement of the quality management system. Provision of internal and external trainings. Acting as a GCP helpdesk for employees. Hosting Clients’ audits.

Past Experience

  • Senior CRA Moscow, Russia
    February 2011 --- March 2015

    Official duties: Site administrating and site monitoring responsibility for clinical studies. Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor. Completing SAE reporting, processing production of reports. Negotiating study budgets with potential investigators and assisting legal department with statements of agreements as assigned. Assisting with training, mentoring, and development of new employees, e.g. co-monitoring. Identifying new sites and drawing them in Client clinical studies. Therapeutic experience‎: oncology, neurology, cardiology, endocrinology.

  • Clinical Research Associate (CRA) Moscow, Russia
    August 2009 --- February 2011

    Official duties: Investigational site management. Therapeutic experience‎: oncology, vaccines.

  • Clinical Research Associate (CRA) Moscow, Russia
    July 2007 --- August 2009

    Official duties: Investigational site management. Therapeutic experience‎: oncology, rheumatology.

Knowledge

Self Assessment :
Good Clinical Practice (GCP)Good Distribution Practice (GDP)Good Laboratory Practice (GLP) Phase I Scientific writingCAPAClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsClinical trialsCompliance with regulationsCROGXPICH guidelinesPharmaceutical ResearchPhases of clinical development (phase I to IV)Quality AssuranceTranslationQuality AuditingQuality ManagementQuality Management System (QMS)Standard Operating Procedure (SOP)Writing Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Analytical skills Assure medical quality Create SOPsAssess quality process issuesDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationPrepare external auditsRespond to audit findingsReview quality control activitiesReview quality policiesSet-up quality policiesTrain Staff

Education

  • Ph.D. in Biology from Lomonosov Moscow State University in 2006
  • Master in Microbiology from Lomonosov Moscow State University in 2003

Training and Certification

  • Professional Communication Translator in 2016 Training
  • Data Management for Clinical Research in 2017 Certification
  • Audit Analysis and Reporting (RQA) in 2016 Certification
  • Bioanalytical, statistical and regulatory aspects of Bioequivalence studies in 2016 Certification
  • The GDP Audit How to conduct and pass GDP Audits and Inspections (ECA) in 2016 Certification
  • Conflict management skills & manipulation resistance in 2015 Certification
  • Principles of organization and conduct of pre-clinical studies according to GLP in 2015 Certification
  • Quality Management System implementation and improvement in accordance with ISO 9001 in 2015 Certification
  • The Auditing Course (RQA) in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Russian
Native
English
Professional Proficiency

Area / Region

Moscow, Russia

Others

Driving License
  • No