1. Constantine Suvorov MD,
Senior Clinical Research Associate
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.
17-Feb-2017Generated on: Constantine Suvorov 25-Nov-2016Accuracy of CV confirmed by on:
ofPage 1 4
Quality-conscious clinical research associate with more than 5 years' experience in Phase II and Phase III of clinical trials.Therapeutic
experience includes the following nosology: oncology,hematology, gastroenterology, immunology. More than 3 years involvement in Oncology
studies. Responsibilities have included site initiation, monitoring, source document verification, sites' close-out. 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 Senior Clinical Research Associate
Company/Location PRA Health Sciences, St.Perersburg, Russia, RUSSIA
Dates Aug 2014- Present 2 yrs, 6 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
• Facilitates audits and audit resolution
• Ensures all required training is completed and documented
• Updates applicable tracking systems
• Communicates with investigative sites
• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP
guidelines
• Assesses IP accountability, dispensation, and compliance at the investigative sites
• Performs source document verification and query resolution
• Performs essential document site file reconciliation
• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
• 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
• Provides regular site status information to team members, trial management, and updates trial
management tools
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
• 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
• If responsible for supervising other CRAs: Schedules and reviews trial tasks, provides leadership in
the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with
PRA’s policies, procedures, and SOPs, and ensures HR processes are properly implemented
• Serves as a Preceptor for new CRAs participating in the CRA Bridge Program
• Functions independently with minimal oversight required
• May serve as subject matter expert for CTM on monitoring related activities
• May be assigned to complex studies and/or sites
• Provides leadership skills to assigned projects and within the Clinical Operations department
Title CRA
Company/Location Pharmaceutical Product Development (PPD), St.Petersburg, Russia, RUSSIA
Dates Sep 2012- Jan 2013 4 mos
Responsibilities • Worked with asssigned sites by PPD as a subcontractor from Accell Clinical
Research.Communicated with the sites.Reviewed and verified accuracy of clinical data collected,
either on site or remotely and was responsible for interim monitiring an close-outs of the assigned
sites.
Accomplishments • Provided interim monitoring and close-out all assigned sites.Completed monitoring activity
documents as required on contractual obligations
Title CRA
Company/Location Accell Clinical Research, St.Petersburg, Russia, RUSSIA
Dates Aug 2011- Jul 2014 2 yrs, 11 mos
Responsibilities • Organised investigator’s start-up meeting and study site initiation meetings.
• Monitored the assigned clinical trial following company SOPs and in accordance with GCP
2. Constantine Suvorov MD,
Senior Clinical Research Associate
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.
17-Feb-2017Generated on: Constantine Suvorov 25-Nov-2016Accuracy of CV confirmed by on:
ofPage 2 4
• Was the point of first contact when investigators/site personnel enquire about patient
inclusion/exclusion criteria for ongoing trials.
• Participated in global conference calls and meetings to review progress of ongoing clinical trials.
• Managed patient recruitment strategies to increase patient randomisation into the trial (eg
investigator meetings, update newsletters, advertising, letters to GPs).
• Maintained projects files including: ethics committee approvals; curricula vitae of investigators and
study personnel; clinical investigators brochure; protocols; case report forms instructions;
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
Certificate of Completion, May 1996
Moscow Linguistic University, Moscow, Russia, Moscow, Russia, RUSSIA
Diploma MD, May 1993
Medical academy, Moscow, Russia, Moscow, Russia, RUSSIA
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
Clinical
Research
Associate
1 4 mos III ADULTS
Gastroenterology Gastrointestinal
Disorders
Necrotizing
Enterocolitis
Clinical
Research
Associate
1 4 mos III ADULTS
Genitourinary Women's Health Contraception Clinical
Research
Associate
1 5 mos III
Hematology Myeloproliferative
Disorders
Myelofibrosis Clinical
Research
Associate
1 1 yr, 1 mo III ADULTS
Immunology Autoimmune
Disorders
Juvenile Idiopathic
Arthritis
Clinical
Research
Associate
1 1 yr, 5 mos III Rare Disease,
PEDIATRICS
Oncology Solid Tumors Breast Clinical
Research
Associate
1 11 mos III Oncology
Subjects
Oncology Solid Tumors Head & Neck Clinical
Research
Associate
1 8 mos III ADULTS
Oncology Solid Tumors Soft Tissue
sarcomas
Clinical
Research
Associate
1 2 yrs, 5 mos III Oncology
Subjects
Geographic Experience
3. Constantine Suvorov MD,
Senior Clinical Research Associate
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.
17-Feb-2017Generated on: Constantine Suvorov 25-Nov-2016Accuracy of CV confirmed by on:
ofPage 3 4
Country or Region Therapeutic Area Role
CENTRAL EUROPE Genitourinary Clinical Research
Associate
EASTERN ASIA Genitourinary Clinical Research
Associate
EASTERN EUROPE Genitourinary Clinical Research
Associate
RUSSIA Cardio-Metabolic Diseases, Gastroenterology, Hematology,
Immunology, Oncology
Clinical Research
Associate
Drug Type Experience
Drug Type Therapeutic Area Subject Population
Biologic Oncology ADULTS
Chemical Entity Cardio-Metabolic Diseases, Hematology, Gastroenterology,
Immunology, Oncology
ADULTS, Rare Disease,
PEDIATRICS, Oncology
Subjects
Environment Experience
Environment Therapeutic Area Subject Population
Doctor's Office Genitourinary
In-patient Oncology ADULTS
Out-patient Cardio-Metabolic Diseases, Hematology,
Gastroenterology, Immunology, Oncology
ADULTS, Rare Disease, PEDIATRICS,
Oncology Subjects
System Experience
Type System Name
EDC Datalabs
IVRS/IWRS/RTSM Merge, ClinPhone IVRS
Certificates
GCP training course, Accell Clinical Research, RUSSIA
Acquired Date: Jun 2014
Expiration Date:
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 UCB Extranet for RDC, DataLabs
EDC/ eDiary / e-PRO Medidata
IXRS Clinphone
Languages/Fluency
4. Constantine Suvorov MD,
Senior Clinical Research Associate
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.
17-Feb-2017Generated on: Constantine Suvorov 25-Nov-2016Accuracy of CV confirmed by on:
ofPage 4 4
Language Conversational Reading Writing
Medical
Records/Terminology
English High High High High
French Low Low Low Low
Russian High High High High