Зоя

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Name & Critical Contact Details

Company/Institution Name:
Zaporizhzhia State Medical University, Ukraine, Zaporizhzhia, Ukraine

Address1:
26 Mayakovsky street, Zaporizhzhia

Address2:
69035, Ukraine

Email Address:
[открыть контакты](см. выше в блоке «контактная информация»)

Phone:
[открыть контакты](см. выше в блоке «контактная информация»)

Facilities Affiliations

Primary Facility
Facility/Department Name
Address
SI “Zaporizhzhia State Medical University”

26 Mayakovsky street, Zaporizhzhia
69126, Ukraine
Education
Degree/Certificate
Institution
Specialty
Year Completed
MD
Zaporizhzhia Medical Academy of Post- Graduate Education of MoH of Ukraine
laboratory diagnostics
2016
MD
Zaporizhzhia State Medical University, Ukraine, Zaporizhzhia, Ukraine
laboratory diagnostics
2014-2015
MD
Zaporizhzhia State Medical University, Ukraine, Zaporizhzhia, Ukraine
laboratory diagnostics
2012 - 2014
BD
Zaporizhzhia State Medical University, Ukraine, Zaporizhzhia, Ukraine
laboratory diagnostics
2007-2011

Professional Experience
Job Title
Institution/ Department
Year Started
Year Completed
Assistant at the Department of Pathological Anatomy and Forensic Medicine
SI “Zaporizhzhia State Medical University, Ukraine, Zaporizhzhia, Ukraine
2014
till present
(maternity leave)

Senior Laboratory Assistant, Department of Pathological Anatomy and Forensic Medicine
SI “Zaporizhzhia State Medical University, Ukraine, Zaporizhzhia, Ukraine”
2011
2014

License Details

Type
of License

License Issuer
Professional License Number
State,
Province or Region

Country
Issue
Date
Expiration Date
Laboratory diagnostics
Zaporizhzhia State Medical University
AP 41539000
Zaporizhzhia
Ukraine
01.09.2007
24.06.2011
Laboratory diagnostics
Zaporizhzhia State Medical University
AP 47204429
Zaporizhzhia
Ukraine
01.09.2011
28.02.2014
Laboratory diagnostics
Zaporizhzhia State Medical University
ЗМ 10313
Zaporizhzhia
Ukraine
30.06.2015
30.06.2020
Laboratory diagnostics
Zaporizhzhia Medical Academy of Post- Graduate Education of MoH of Ukraine
11619
Zaporizhzhia
Ukraine
10.06.2016
10.06.2021

Research Experience:

SUB-INVESTIGATOR: April 2016 – September 2020

Therapeutic Areas
Sub-Therapeutic Area, Phase
Number of Completed Studies
Number of
Ongoing Studies
Cardiology
Hyperlipidemia, Angina Pectoris (Phase II, III)
2
0
Pulmonology
COPD (Phase III)
1
0
Gastroenterology
Ulcerative colitis (Phase II,)
1
0

Responsibility:

Freelance CRA: September 2020 – February 2023

Therapeutic Areas
Sub-Therapeutic Area, Phase
Number of Completed Studies
Number of
Ongoing Studies
Gastroenterology
Ulcerative colitis (Phase II,)
1
1
Immunology
Vaccination (Phase III)
1
1

Responsibility:

•Sites selection, collecting the documents for CEC/IRB approvals
•Sites initiation and start-up activity
•Obtaining necessary documentation and information from investigators. Completing monitoring visits to sites and reports as required by client contract deadlines. Performing drug accountability at Study sites.
•Data review and reconciliation, verification against source documents. Ensuring timely sending of completed CRF pages or data corrections to Data Management.
•Recruit investigators for participation in clinical trials.
•Negotiate study budgets with investigators
•Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites.
•Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ Meetings.
•Ongoing support of the site staff in resolution of any trial-related issues, protocol-specific training and re-training.
•Creating the Blinded Plan for site staff for Blinded and Unblinded participants of a trial.
•Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
•Manage Serious Adverse Event (SAE) reporting, process production of reports, review, follow-up and submitted SAE reports to Ethics/Regulatory authorities, whenever applicable.
•Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
•Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
•Close-out activities (drug reconciliation and accountability etc).

SIGNATURE (Please follow the direction of the Sponsor in completing this field.)

By signing this form, I confirm that the information provided on this Abbreviated CV is accurate and reflects my current employment and qualifications:

Signature: Date: __________