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
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
Hanna
Medical Monitor, Safety Physician
Київ
повна зайнятість
Оновлено 2 місяці тому