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NAMEVitaliy Tserkovnyak, MD


EDUCATION

2003, 2015 Medical Doctor (radiology specialization)
Kyiv Medical Academy Post-Graduate Education named after Shupik, Kyiv, Ukraine

1998-2000Medical Doctor (surgery specialization)
Strazhesko Research Cardiology Institute, Kyiv, Ukraine

1992-1998Medical Doctor (GMP)
National Medical Bohomolets University, Kyiv, Ukraine

1988-1992First-aid man
Medical College #2, Kyiv, Ukraine

PROFESSIONAL EXPERIENCE

12Apr2016 to 04Dec2017Sr. Clinical Research Associate
AstraZeneca Ukraine LLC
Kyiv, Ukraine



Nov 2012 to 05Feb2016Clinical Research Associate II
PharmaNet/i3 (inVentiv Health Company)
Kyiv, Ukraine

•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


Apr 2011 to Oct 2012Clinical Research Associate II
PPD Ukraine, Kyiv, Ukraine
•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


PROFESSIONAL EXPERIENCE, CONTINUED

Sep 2008 to Apr 2011Clinical Research Associate
PSI Ukraine,Kyiv, Ukraine



PROFESSIONAL MEMBERSHIPS

Member of Ukraine Radiology Society since 2003-I do scientific work on parathyroid scintigraphy (six articles in national radiological journals, 2 presentations at Ukraine Radiology Society).



FOREIGN LANGUAGES
UkrainianSpeak and Read
RussianSpeak and Read
EnglishSpeak and Read



SUMMARY OF PROJECT EXPERIENCE

Therapeutic Area, Sub Indication and Drug ClassPhaseJob Title
Oncology/Metastatic Colorectal Cancer/monoclonal antibodies to VEGFIIbCRA
Oncology/Advanced Renal Cell Carcinoma/InterferoneII/IIICRA
Neurology/Relapsing-Remitting Multiple Sclerosis/ monoclonal antibodiesIIICRA
Rheumatology/Gout flare treatment/ monoclonal antibodies to NKIIICRA
Rheumatology/Gout flare treatment (Extension1) / monoclonal antibodies to NKIIICRA
Oncology/Pegfilgrastim in Subjects with Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)IIICRA
Oncology/Advanced Non-Small Cell Lung Cancer Treatment/ monoclonal antibodies to VEGFIIICRA
Oncology/Advanced Non-Small Cell Lung Cancer Treatment/ monoclonal antibodies to VEGFIIICRA
Oncology/Prostate cancer/ monoclonal antibodies to VEGFIIICRAII
Neurology/Cervical Dystonia/ botulinum toxin
IICRAII
Cardiology/Reduction of Cardiovascular Events with EPAIIIbCRAII
Pulmonology/monoclonal antibodies in BA treatment IIIbSrCRA
Pulmonology/monoclonal antibodies in BA treatment IIIbSrCRA
Pulmonology/monoclonal antibodies in BA treatmentIIIbSrCRA




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