Constantine Suvorov Email & Phone Number

St Petersburg, St Petersburg City, Russia

64, Building 1, Lit. A, Serdobolskaya Street, St. Petersburg, Russia

Quality-conscious Clinical Research Associate with 6 and a half years of experience in Phase IIand Phase III of clinical trials. Therapeutic experience includes the following nosology:oncology, hematology, gastroenterology, pediatric rheumatology and immunology. I havemore than 4,5 years’ involvement in Oncology studies. Responsibilities have included siteinitiation, monitoring, source document verification, sites close-out. Competent with thesystems used for clinical trial management (CTMS, RDC, IWRS). Vendors experienceincludes IWRS, LabCorp, Perceptive. Proper organizational, record retention, timemanagement and decision making skills.

Saint Petersburg, Russian Federation 4A Finlyandsky Pr., Suite 223

My knowledge as Senior Certified Clinical Research Associate includes the following: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 Complete monitoring activity documents as required by PRA SOPs or other contractual obligations. Works 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

4A Finlyandsky Pr., St.Petersburg, 194044 ∙ Russia

Monitoring clinical sites in Russia to ensure compliance with study protocols and adherence to ICH Good Clinical Practice, EU Directive and Russian Regulatory requirements; collaborating with various departments of the company; writing reports and maintaining business correspondence, involved in multi-national project teams being a proactive and energetic team player.

Certificate Of Completion, Clinical Research Field

Activities and Societies: CRA training sessionsCRA Certified course

T.E.S.O.L. Diploma, Tesol Course

Activities and Societies: Obtaining TESOL DiplomaObtaining TESOL Diploma

Bachelor'S Degree, Medical Translation

Activities and Societies: Debate teamHigher Education (MD Diploma|)

Doctor Of Medicine (Md), Medicine

Activities and Societies: Scientific research groupHigher Education (MD)