1. Constantine Suvorov, MD
Clinical Research Associate II
Curriculum Vitae
This employee information has been disclosed solely for the purpose of the recipient verifying the clinical experience and qualifications of the individual PRA employee. As the Data Controller,
PRA requires that data confidentiality is maintained with no unauthorized onward disclosure and that it is destroyed when the purpose is fulfilled.
4 - Mar - 2015Generated on: Constantine Suvorov 2 - Mar - 2015Last Updated by on:
Quality-conscious clinical research associate with more than three years' experience in Phase II and Phase III of clinical trials. Responsibilities
have included site initiation, monitoring, source document verification, sites' close-out. Therapeutic experience includes oncology,hematology
and gastroenterology.Competent with the systems used for clinical trial management (CTMS, RDC, IWRS).Vendors experience includes
IWRS,LabCorp,Perceptive.Proper organizational,record retention,time management and decision making skills.
Work History
Title Clinical Research Associate II
Company/Location PRA Health Sciences, St.Perersburg, Russia, RUSSIA
Dates Aug 2014- Present 7 mos
Responsibilities • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met
and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites,
instructs site personnel on the proper conduct of clinical trials, and close clinical trials at
investigative sites
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
• Provides regular site status information to team members, trial management, and updates trial
management tools
• Completes monitoring activity documents as required by PRA SOPs or other contractual
obligationsWorks closely with other clinical team members to facilitate timely resolution of trial
and/or clinical issues
• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
• Performs essential document site file reconciliation
• Performs source document verification and query resolution
• Assesses IP accountability, dispensation, and compliance at the investigative sites
• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP
guidelines
• Communicates with investigative sites
• Updates applicable tracking systems
• Ensures all required training is completed and documented
• Facilitates audits and audit resolution
Title CRA
Company/Location Pharmaceutical Product Development (PPD), St.Petersburg, Russia, RUSSIA
Dates Sep 2012 - Jan 2013 4 mos
Title CRA
Company/Location Accell Clinical Research, St.Petersburg, Russia, RUSSIA
Dates Aug 2011 - Jul 2014 2 yrs, 11 mos
Education
Graduate, T.E.S.O.L. Diploma, Oct 2010
ATC-Academy of Languages and Training, Vancouver, British Columbia, CANADA
Graduate, CRA Certificate of Completion, May 2008
Kriger research Institute, Toronto, Canada, Toronto, Ontario, CANADA
Other, Certificate of Completion, May 1996
Moscow Linguistic University, Moscow, Russia, Moscow, Russia, RUSSIA
Other, Diploma MD, May 1993
Medical academy, Moscow, Russia, Moscow, Russia, RUSSIA
2. Constantine Suvorov, MD
Clinical Research Associate II
Curriculum Vitae
This employee information has been disclosed solely for the purpose of the recipient verifying the clinical experience and qualifications of the individual PRA employee. As the Data Controller,
PRA requires that data confidentiality is maintained with no unauthorized onward disclosure and that it is destroyed when the purpose is fulfilled.
4 - Mar - 2015Generated on: Constantine Suvorov 2 - Mar - 2015Last Updated by on:
Protocol Therapeutic Experience
Therapeutic Area
Indication
Group
Primary
Indication
Role
Number
of Studies
Duration Phase
Subject
Population
Cardio-Metabolic
Diseases
Peripheral Vascular
Disease
Venous
Thromboembolism
2 4 mos III ADULTS
Gastroenterology Gastrointestinal
Disorders
Necrotizing
Enterocolitis
1 4 mos III ADULTS
Hematology Myeloproliferative
Disorders
Myelofibrosis 1 1 yr, 1 mo III ADULTS
Oncology Solid Tumors Breast 1 6 mos III Oncology
Subjects
Oncology Solid Tumors Head & Neck 1 8 mos III ADULTS
Oncology Solid Tumors Soft Tissue
sarcomas
1 5 mos III Oncology
Subjects
Geographic Experience
Country or Region Therapeutic Area Role
RUSSIA Oncology
Drug Type Experience
Drug Type Therapeutic Area Subject Population
Biologic Oncology ADULTS
Chemical Entity Cardio-Metabolic Diseases, Oncology, Hematology,
Gastroenterology
Oncology Subjects,
ADULTS
Environment Experience
Environment Therapeutic Area Subject Population
In-patient Oncology ADULTS
Out-patient Cardio-Metabolic Diseases, Hematology,
Oncology, Gastroenterology
Oncology Subjects, ADULTS
System Experience
Type System Name
EDC Datalabs
IVRS/IWRS/RTSM ClinPhone IVRS, Merge
Certificates
GCP training course, Accell Clinical Research, RUSSIA
Acquired Date: Jun 2014
Expiration Date:
3. Constantine Suvorov, MD
Clinical Research Associate II
Curriculum Vitae
This employee information has been disclosed solely for the purpose of the recipient verifying the clinical experience and qualifications of the individual PRA employee. As the Data Controller,
PRA requires that data confidentiality is maintained with no unauthorized onward disclosure and that it is destroyed when the purpose is fulfilled.
4 - Mar - 2015Generated on: Constantine Suvorov 2 - Mar - 2015Last Updated by on:
CRA training programm, Kriger Research Institute, CANADA
Acquired Date: Jun 2008
Expiration Date:
Vendor Experience
Type Name
Central Imaging Services Perceptive
Central Lab Services LabCorp, LabStar Clinical Management System
Clinical Data Management CTMS
EDC / eDiary / e-PRO DataLabs
EDC/ eDiary / e-PRO Medidata
IXRS Clinphone
Languages/Fluency
Language Conversational Reading/Writing Medical Terminology
English High High High
Russian High High High