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Work experience

SrCRA

from 04.2016 to 12.2017 (1 year 9 months)
AstraZeneca, Київ (Medicine, pharmacy)

Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to PSI SOPs and/or client guidelines
•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
•Prepare and process Serious Adverse Event (SAE) reports
•Prepare project management reports for clients, project personnel, and PSI management
•Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
•Resolve queries of CRF data with study site personnel
•Review Tables and Listings generated from study data
•Assist in writing Clinical Study Reports
•Train junior CRAs on monitoring, internal procedures, and query resolution
•When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority

CRA

from 11.2012 to 02.2016 (3 years 4 months)
inVentiv, Київ (Medicine, pharmacy)

Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to PSI SOPs and/or client guidelines
•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
•Prepare and process Serious Adverse Event (SAE) reports
•Prepare project management reports for clients, project personnel, and PSI management
•Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
•Resolve queries of CRF data with study site personnel
•Review Tables and Listings generated from study data
•Assist in writing Clinical Study Reports
•Train junior CRAs on monitoring, internal procedures, and query resolution
•When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority

CRA II

from 04.2011 to 10.2012 (1 year 7 months)
PPD Ukraine, Kyiv, Ukraine, Київ (Medicine, pharmacy)

•Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to PPD SOPs and/or client guidelines
•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
•Prepare and process Serious Adverse Event (SAE) reports
•Prepare project management reports for clients, project personnel, and PPD management
•Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
•Resolve queries of CRF data with study site
personnel
•Review Tables and Listings generated from study data
•Assist in writing Clinical Study Reports
•When allocated by study management, submit essential/required documents to a Local IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority
•Lead CRA in oncology trail during one year

Clinical Research Associate

from 09.2008 to 04.2011 (2 years 8 months)
PSI Ukraine,Kyiv, Ukraine, Київ (Medicine, pharmacy)

Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to PSI SOPs and/or client guidelines
•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
•Prepare and process Serious Adverse Event (SAE) reports
•Prepare project management reports for clients, project personnel, and PSI management
•Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
•Resolve queries of CRF data with study site personnel
•Review Tables and Listings generated from study data
•Assist in writing Clinical Study Reports
•Train junior CRAs on monitoring, internal procedures, and query resolution
•When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority

Education

National Medical Bohomolets University, Kyiv, Ukraine

Medical, Київ
Higher, from 1992 to 1998 (6 years)

Additional education and certificates

Medical College #2, Kyiv, Ukraine

1988-1992

Medical Doctor (surgery specialization), Strazhesko Research Cardiology Institute, Kyiv, Ukraine

1998-2000

Medical Doctor (radiology specialization) Kyiv Medical Academy Post-Graduate Education named after Shupik

2003, 2015

Member of Ukraine Radiology Society

2003-present