1. Yuriy Kravtsiv CV (updated on May 25, 2015) Page 1 of 5
Curriculum Vitae
Yuriy Kravtsiv, MD
+38 .067 .247 .19 .24
+38 .063 .919 .79 .11
+38 .093 .670 .48 .10
Yuriy.Kravtsiv@gmail.com
Skype: yuriko321
Summary
• 3 years of scientific research experience in Clinical Immunology.
• 8 years of experience in clinical studies and participation in pre-clinical studies.
• Medical Psychologist experience.
Therapeutic Areas of Experience
• Infectious Diseases:
• Gastroenterology:
• Cardiology:
• Psychiatry:
• Oncology:
• Pulmonology:
Hospital acquired Pneumonia, III phase study.
Community-acquired pneumonia, III phase study.
Severe ulcerative colitis, monoclonal antibodies therapy, II phase
study. Moderately active ulcerative colitis, III phase study.
Arrhythmia, Acute Coronary Syndrome II-III phase study.
Chronic Schizophrenia, III phase study.
Non-small cell Lung Cancer after failure of first line chemotherapy, III
phase study.
Severe or moderate Airway Obstruction in COPD patients, IV phase
study.
Moderate COPD and a history of increased risk of cardiovascular
disease, III phase study.
Work Experience
September 2013 –
Present
Therapy-now, home based
Medical Psychologist
• Conducting on-line consultation that helps to fix problems in
communication, relationship, depression, self growth,
anxiety/fears/panic, abuse recovery (sexual, physical and emotional),
trauma and age-related crisis or lost personal goals.
October 2008 –
August 2013
PAREXEL Ukraine LLC, Kyiv Ukraine
Senior Clinical Research Associate
• Communication - Maintains timely and effective communication
among team members and site staff. Routinely anticipates/identifies
potential issues and implements corrective actions independently. Keeps
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project leadership apprised of team issues, seeking guidance as needed.
Demonstrates effective conflict resolution.
• Regulatory Documentation - Assures compliance with local
regulations, Code of Federal Regulations (CFR)/ International
Conference of Harmonization (ICH) and GCP guidelines, and Company
and Sponsor SOPs. Maintains current regulatory documentation. May be
responsible for submission of regulatory packages to ethics committees
and/or competent authorities.
• Monitoring - Responsible for site management and site staff
performance including: participates in all types of site visits; assures
compliance with all protocol requirements; assures effective patient
identification and recruitment plan is in place; assures timely reporting
of Adverse Events and protocol violations; may perform assessment and
trainings of less experienced CRAs.
• Data Handling - Performs source data verification according to
contractual requirements. Assures timely completion and submission of
Case Report Forms according to Clinical Monitoring Plan and/or Data
Management Plan. Performs clinical data listings reviews as needed.
Quality checks and audit preparation.
• Reporting and Tracking - Completes and submits reports according to
SOP/Works Instructions requiring minimal revisions. Maintains
awareness of key study performance indicators for own sites, e.g. Tracks
Investigator payments/milestones. Documents and tracks the query
resolution.
• Administrative - Prepares for and attends Investigator meetings. May
present materials, as requested. Assists with the preparation of study
start-up materials and tools, as requested. Attends clinical monitoring
staff meetings, project team meetings, and clinical training sessions.
• Developing of strategic plans for clinical studies, forecast timelines,
budgets, resource need in alignment with the Clinical Operations Team
objectives.
October 2007 –
October 2008
PAREXEL Ukraine LLC, Kyiv Ukraine
Clinical Research Associate II
• Provides timely and effective communication among team members
and site staff.
• Maintains current regulatory documentation compliant with CFR,
State regulations, ICH and GCP guidelines and sponsor or PXL SOPs.
• Participates in on-site audits as requested.
• Responsible for site management and site staff performance including:
assures Principal Investigator (PI) integrity; assures compliance with all
protocol requirements; assures effective patient identification and
recruitment plan is in place; assures timely reporting of AEs/ SAEs and
Protocol Violations; regularly performs Investigational Product (IP)
accountability and reviews the status of contents of the site Regulatory
Binder.
• Resolves problematic issues in a productive way and exhibits effective
time management skills.
• Provides shadowing observation visits for other CRAs.
• Performs source document verification (SDV) according to
contractual requirements.
• Assures timely completion and submission of CRFs according to
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Clinical Monitoring Plan (CMP) and / or Data Management Plan
(DMP).
• Assures timely and accurate completion of Data Clarification Forms
(DCFs).
• Performs clinical data listings reviews as needed.
• Completes and submits visit reports according to SOP/WI or sponsor
requirements and requiring minimal revisions.
• Reviews visit reports.
• Updates study and patient status information and serves as (CTMS)
resource for PM/LCRA.
• Tracks Investigator payments/ milestones, if requested.
• Documents and tracks the resolution of all outstanding site-specific
protocol-related issues from visit to visit.
• Prepares for and attends investigator’s meetings as requested.
February 2006 –
October 2007
PAREXEL Ukraine LLC, Kyiv Ukraine
Clinical Research Associate I
• Performing initial contact and participating in the assessment and
selection of qualified investigators for inclusion in clinical programs.
• Performing Pre-Selection, Selection, Initiation, Monitoring, and
Close-out site visits and ensuring data standards are met.
• Contributing to the preparation of study documentation such as
protocol amendments, Informed Consent etc.
• Collecting and processing regulatory documents and correspondence.
• Carrying out the training of the investigators in the study-specific
documents (Investigators' Brochure, Study Protocol, other study-
specific guidelines and manuals).
• Ensuring that the investigator adhere to the study protocol, current
GCP guidelines and regulatory requirements during the study conduct.
• Ensuring that the files for the trial sites and in house site files are up to
date, accurate and include all essential documents as detailed in ICH
GCP guidelines.
• Reviewing and comparing clinical trial site data with patient records
(Source Documentation), in accordance with protocol specific
guidelines.
• Managing data collected from clinical sites, resolution of data queries.
• Checking SAE reports documentation.
• Assistance in the conduct of internal and external audits, in
accordance with applicable SOPs and regulations/guidelines.
• Performing drug accountability procedures in compliance with
protocol.
• Assistance in the coordination of investigator meetings.
• Assistance in the publication review and approval process.
• Participating in potential studies feasibility process.
• Managing of study supplies and study materials shipments to and
from sites, including shipments requests, sites notification, shipments
tracking and collection of confirmations of materials receipt.
• Providing financial reports to the applicable departments in a timely
manner.
November 2005 –
February 2006
PAREXEL Ukraine LLC, Kyiv Ukraine
CRA assistant/CRA trainee
• Managing of study supplies and study materials shipments to and
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from sites, including shipments requests, sites notification, shipments
tracking and collection of confirmations of materials receipt.
• Tracking and resolution of data queries.
• Preparation of study documentation.
• Collecting and processing regulatory documents and correspondence.
Jan uary 2003 –
October 2005
Scientific ResearchLaboratory Center of National Medical
University named after O.O. Bohomolets, Department of
Immunology and Allergology, Kyiv, Ukraine
Clinical Immunologist, Predoctoral Research Associate
• Reception of immunocompromised patients.
• Performing diagnostic tests and medical examination.
• Prescribing of corresponding treatment according to the local
standards.
• Introduction of modern diagnostic procedures as Flow Cytometry and
Polymerase Chain Reaction etc.
November 2000 –
January 2003
Ukrashow LLC, Kyiv, Ukraine,
Medical Consultant
• Conducting of Electro Acupuncture according to Voll.
• Prescribing of homeopathy treatment.
September 1995 –
July 1998
Ivano-Frankivsk Regional Emergency Medical Center,
Ivano-Frankivsk, Ukraine
Medical attendant
Education and Qualifications
2008 – 2011 Interregional Academy of Personnel Management, Sevastopol,
Ukraine,
Qualified Specialist in Practical Psychology.
2005 – 2013 PAREXEL Ukraine LLC, Kyiv Ukraine
Ongoing PAREXEL trainings
2004 – 2004 D. Galitsky State Medical University, Lviv, Ukraine,
In service training in Clinical Immunology.
2000 – 2000 Schiller International University, Waterloo Campus, London, UK
Fundamentals of International Marketing and Information Technology.
1999 – 2000 National Medical University named after O.O. Bohomolets, Kyiv,
Ukraine,
Qualified Specialist in Internal Medicine (internship)
1992 – 1998 State Medical Academy, Ivano-Frankivsk, Ukraine,
Medical doctor
Languages
Ukrainian, Russian – native, English – fluent
Skills
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• Good organizational and time management skills;
• Quality management;
• Regulatory management;
• Problem solving;
• Teamwork;
• Mentoring;
• Communication and negotiation skills;
• High knowledge of clinical research regulations and practices;
• Advanced PC user (MS Office, IMPACT, Oracle Clinical, EDC, eCRF, Lotus Notes, Inform,
web development)
