Резюме від 27 листопада 2014

Max

Clinical Research Associate (CRA)

Зайнятість:
Повна зайнятість.
Вік:
46 років
Місто:
Київ

Контактна інформація

Шукач вказав телефон та ел. пошту.

Прізвище, контакти та світлина доступні тільки для зареєстрованих роботодавців. Щоб отримати доступ до особистих даних кандидатів, увійдіть як роботодавець або зареєструйтеся.

Додаткова інформація

Curriculum Vitae
Name: Shepetko Maxim Vladimirovich, MD, PhD
Address: 124 Frunze str., 162. Kiev, Ukraine 04080
Phone: [відкрити контакти](див. вище в блоці «контактна інформація»)
e-мail: [відкрити контакти](див. вище в блоці «контактна інформація»)
Age: 37 years
Aim: Clinical Research Associate position with potential for long-
term growth and self-improvement
Work experience:
02.2013 – to present Pharmaceutical firm "Darnitsa". Head of the Clinical Trials
Group.
11. 2011 – 02.2013 Pharmaceutical corporation «Arterium». Specialist of clinical
trials.
11. 2008 –11. 2011 Researcher, Department of Experimental Therapeutics, Institute
of Pharmacology and Toxicology, Academy of Medical
Sciences, Kyiv, Ukraine.
09. 2005 – 10. 2008 Postgraduate in Pharmacology (Ph.D.), Department of
Experimental Therapeutics, Institute of Pharmacology and
Toxicology, Academy of Medical Sciences, Kyiv, Ukraine.
09. 2001 – 10. 2005 Leading team specialist of information systematization of State
Pharmacological Centre of MoH of Ukraine. Kyiv, Ukraine.
Last workplace:
- Site selection, initiation, interim monitoring visits, co
monitoring visits, study close-out;
- recruiting investigator;
- Training the site staff on the protocol, study procedures and
regulatory requirements;
- edit clinical study reports;
- verifying that data entered on to the CRF is consistent with
source documents (SDV);
- collecting completed CRFs;
- perform IP and clinical trial accountability;
- writing monitoring visit reports;
- work with PVG officer to clarify, respond, resolve and report
AE/SAE as they arise;
- filing trial documentation and reports;
- participate in vendor selection and management;
- assist with preparation of regulatory submissions;
- liaising with consultants on the development of clinical study
protocols and CRFs;
- development of investigator brochures, package inserts, IP
dossier, study guidlines;
- development and review ICF;
- discussing trial results with biostatistican to write final study
report;

Education:
2006 - 2009 Institute of Pharmacology and Toxicology Academy of Medical
Science of Ukraine, Kyiv, Ukraine (PhD degree).
2001- 2003 National Medical Academy of Postgraduate Education, Kyiv,
Ukraine (orthopedics and traumatology).
1995 - 2001 Uzhorod National University, Ukraine (General Medicine,
Biomedical electronics).
Languages: Russian, Ukrainian, English (upper intermediate).
Skills: Well acquainted with ICH GCP Guidelines. Have experience in
translating and editing scientific texts.
PC: advanced user, driver's license (B cat.).
Hobby: Radioelectronics.
About myself: Responsible, serious, well organized person.

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