Працювала в 2 компаніях   3 роки 8 місяців

Медицина та Охорона здоров'я, Фармацевтика

Clinical Research Associate

Syneos Hhealth

Медицина та Охорона здоров'я

2 роки 10 місяців

07.2021 - до теперішнього часу

  • Conduct pre-study, study initiation, interim monitoring visits and final close out visits in adherence to the protocol requirements.
  • Review study subject safety information, informed consent, monitor AEs, SAEs, AESI registration and reporting.
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Re-train sites on Protocol requirements, assist in query resolution, and monitor adverse events, serious adverse events and adverse events of special interest registration and reporting, etc.
  • Perform feasibility search of potential sites, identify new sites, establish good relationships with key groups of medical specialists and represent the company.
  • Other duties as assigned.

Clinical Research Associate

PRA Health Sciences

Фармацевтика

9 місяців

10.2020 - 07.2021

  • Conduct pre-study, study initiation, interim monitoring visits and final close out visits in adherence to the protocol requirements.
  • Review study subject safety information, informed consent, monitor AEs, SAEs, AESI registration and reporting.
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Re-train sites on Protocol requirements, assist in query resolution, and monitor adverse events, serious adverse events and adverse events of special interest registration and reporting, etc.
  • Perform feasibility search of potential sites, identify new sites, establish good relationships with key groups of medical specialists and represent the company.
  • Other duties as assigned.

Ключова інформація

Medicine, Clinical Research,

Rare Disease,

Good Clinical Practice,

Good Pharmacovigilance Practice

Electronic Data Capture Systems (Medidata, InForm, IBM, Everest)

Навчалась в 3 закладах

Kharkiv National Medical University

Master of Education

Kharkiv, 2017

Kharkiv National Medical University

PhD in Medicine

Kharkiv, 2008

Kharkiv National Medical University

Medical Doctor, General Pediatrics

Kharkiv, 2005

Володіє мовами

Англійська

поглиблений

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Російська

рідна

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Українська

рідна

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Курси, тренінги, сертифікати

Practical Clinical Statistics for the Non-Statistician

University of San Diego, 2021

Practical Clinical Statistics for the Non-Statistician

Додаткова інформація

Научная деятельность

Medical Doctor, PhD in Medicine with 15 years' experience in managing patients in wide therapeutic areas, endocrinology and pediatric oncology inclusively. Have strong 15 years academic background. Also, have more then 2,5 years' experience as a CRA in different therapeutic areas, fully trained in all aspects of Good Clinical Practice, global and local regulation requirements. Able to understand, search, create and efficiently communicate complicated scientific and medical data and are able to build positive and productive relationships with cross-functional stakeholders. Strongly understand creation and execution of research studies. Able to provide scientific and medical support of clinical study conduct. Has proven leadership skills in a cross-functional team environment, serving as project manager of education operations, attending physician and clinical researcher in academic environment. Has wide successful experience in communication with KOL's and with relevant patient advocacy groups (cystic fibrosis, spinal muscular atrophy) for investigation areas of mutual interest and potential collaboration. Has good analytical skills, highly motivated, proactive, result-oriented, problem-solving, multitasking, able to gain new and transform skills and experience in new environment.

Hanna

Medical Monitor, Safety Physician

Київ

42 роки

повна зайнятість

Оновлено 2 місяці тому