Curriculum Vitae

Yuriy Kravtsiv, MD+38 .067 .247 .19 .24+38 .063 .919 .79 .11+38 .093 .670 .48 .10Yuriy.Kravtsiv@gmail.comSkype: 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 basedMedical 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 UkraineSenior 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 UkraineClinical 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 UkraineClinical 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 UkraineCRA 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 Research Laboratory Center of National Medical University named after O.O. Bohomolets, Department of Immunology and Allergology, Kyiv, UkraineClinical 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, UkraineMedical attendant

Education and Qualifications

2008 – 2011 Interregional Academy of Personnel Management, Sevastopol, Ukraine,Qualified Specialist in Practical Psychology.

2005 – 2013 PAREXEL Ukraine LLC, Kyiv UkraineOngoing 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, UKFundamentals 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)

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