I am an experienced CRA working in Russia based in Saint-Petersburg. Saint-Petersburg is the best place to travel to every part of Russia in the shortest way in order to spend at the sites as many hours as possible. My experience in clinical research started in June 2008. I continued my career in Novartis Pharma LLC as Lead Clinical Research Associate in August 2017, following 7 years as Senior CRA in PAREXEL International (RUS). My therapeutic experience includes phases II and III adult trials. Since 2008, I’ve been responsible for monitoring activities in more than 40 international clinical trials, conducting different types of activities, including site qualification, initiation, monitoring, termination and quality control visits in Moscow, St-Petersburg and regional sites in Russian Federation. 

Employment history

Lead Clinical Research Associate, Novartis Pharma LLC, Saint-Petersburg, Russia, August 2017 - May 2023 

• Perform the clinical monitoring aspect of designated oncology projects in accordance with applicable SOPs. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), remote visits, collecting regulatory documentation, performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines. Responsible for coordinating a moderate to large team or multiple small size protocols as the CRA Coordinator, with minimal to no supervision. Alternatively, take on the role of a CRA Coordinator on smaller projects. Serve as a resource and mentor to team members, provide support to junior CRAs.

Senior Clinical Research Associate, PAREXEL International (RUS), Saint-Petersburg, Russia, November 2011 - August 2017

Clinical Research Associate II, PAREXEL International RUS, Saint-Petersburg, Russia, March 2010 – November 2011

Clinical Research Associate I-II, Worldwide Clinical Trials (Note: Previous to acquisition in March 2008, company was operated as Evidence CPR), Saint-Petersburg, Russia, June 2008 – March 2010

Chief of Medical Service, Military Forces of Russian Federation, Russia, April 2006 – May 2008

Senior Laboratory Assistant, Department of Clinical Laboratory Diagnostics, I. P. Pavlov Saint-Petersburg State Medical University, Saint-Petersburg, Russia, October 2005 – April 2006

 Education

• CRA Certification Program. CRA: The Pfizer Way Workshop, Moscow, Russia, 21-23 Dec 2010
• EFGCP In-house GCP Training Course for Experienced Researchers, State Medical University, Saint-Petersburg, Russia, 08 Oct 2010
• GRO Site Management Basic Training, PAREXEL, Berlin, Germany, 14-17 Jun 2010
• GSK Advanced Monitoring Course, GSK, Moscow, Russia, 11-13 Aug 2009
• “Good Clinical Practice” course, WCT, Saint-Petersburg, Russia, 28 Apr 2009
• GCP based Advanced CRA Training, WCT, Saint-Petersburg, Russia, 25-26 Sep 2008
• I. P. Pavlov Saint-Petersburg State Medical University, Saint-Petersburg, Russia, Internship in laboratory diagnostics, 2004-2005
• I. P. Pavlov Saint-Petersburg State Medical University, Saint-Petersburg, Russia, GP, 1998-2004