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Work experience

Senior CRA

from 06.2008 to 05.2009 (1 year)
QT Consulting LLC (privately owned CRO). , Kyiv (Clinical research)

Key responsibilities:

•Responsible for sites selection and- initiation, has been assisting and supervising CRA during routine monitoring process;
•Reviewed on-site files and records, source documents and case report forms for completeness, accuracy, consistency, and compliance; identified deficiencies and discrepancies, provided remedial training and/or initiated corrective action as required.
•Participated in weekly teleconferences with sponsor of the study;
•Reviewed monitoring visit reports;
•Prepared protocol amendments submission packages for Ukrainian regulatory authorities; import/export licenses;
•Reviewed and communicated Serious Adverse Events happened within clinical trial at sites with subsequent data transmission to Safety manager and that follow-up activities conducted as necessary;
•Provided the Investigators with logistical and practical advice, training, assistance or support, thus ensuring the clinical trial was conducted in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice, applicable local regulatory requirements and SOPs;
•Reviewed the quality of translated documents, translation of documents;
•Line management (supervision of 2 CRAs, clinical trial assistant).

Clinical Research Associate

from 06.2007 to 05.2008 (1 year)
MB Quest LLC (a member of Pharm-Olam International Group http://www.pharm-olam.com/). , Kyi v (Clinical research)

Key responsibilities:

•Conducted sites selection, initiation, routine monitoring, close-down visits;
•Performed site communication and ensured adequate enrollment rate;
•Verified the subject safety and adherence to FDA regulations and ICH GCP guidelines;
•Monitored the conduct of clinical trial, resolved data discrepancies and ensured complete and accurate data reporting;
•Provided support and timely follow-up for all audit and quality assurance activities.(one of the sites I had been monitoring was audited in August, 2008 and audit resulted in minor findings only);
•Prepared initial submission packages as well as protocol amendments submission packages for Ukrainian regulatory authorities; import/export licenses, etc.;
•Participated in weekly teleconferences with sponsor of the study;
•Communicated with vendors, coordinated custom clearance of study materials, including planning of future site needs;
•Supervised clinical trial assistants;
•Performed feasibility.

CTA

from 02.2006 to 05.2007 (1 year 4 months)
MB Quest LLC (a member of Pharm-Olam International Group http://www.pharm-olam.com/). , Kyi v (Clinical research)

Assisting CRAs in running day-to-day activities

Assistant to Sales and Marketing Departments (Pharmaceutical and Surgical Departments).

from 01.2004 to 12.2005 (2 years)
Representative office of “Alcon Pharmaceuticals Ltd, Kyiv (Pharmaceuticals)

Assistant to Country Manager.

from 07.2002 to 12.2004 (2 years 6 months)
Representative office of “Alcon Pharmaceuticals Ltd, Kyiv (Pharmaceuticals)

Education

National Technical University of Ukraine "Kyiv Polytechnic Institute" (NTUU KPI)

Biotechnology faculty. Specialty: Specialist in biotechnology., Kyiv
Higher, from 2004 to 2006 (2 years)

Melitopol Pedagogical University

Philological faculty. Specialty: Specialist in English and German Philology., Kyiv
Higher, from 1996 to 2001 (5 years)

Additional education and certificates

GCP training, Kyiv, Ukraine

Feb’06,

Initial CRA training, Kyiv, Ukraine

Apr’06

CRA training, Kyiv, Ukraine

Sep’06

CRA training, Moscow, Russia

Nov’06

CRA on-site training, Kyiv – Vinnitsya, Ukraine;

Jul’07

CRA/investigator training on GCP, Kyiv, Ukraine;

Oct’07

Sponsor web-based training on Digital pen use – Kyiv, Ukraine

Apr, 2008

Module on GCP. Essential guidelines – (PharmaSchool, UK). Exam score – 88%.

Aug, 2009

Advanced GCP course, NIDA, USA

Sep, 2009

Knowledge and skills

• MS Office
• PC User
• Adobe
• Adobe Creative Suite
• Creativity

Language proficiencies

• Ukrainian — fluent
• English — advanced
• German — average

Additional information

Therapeutic Experience

•Cardiovascular
Acute Myocardial infarction, Phase II (Jun’08 – May’09)
Symptomatic Arterial Pulmonary Hypertension,
Phase III (Dec’07 – May’08)
Stable angina pectoris, Phase II (Jan’06 – Oct’07)
•Rheumatology
Rheumatoid arthritis, Phase II (Oct’07 – Dec’07)
•Neurology
Multiple sclerosis, Phase II, Feasibility (July’07)


References are available upon request.