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 PAREXEL as Clinical Research Associate II in March 2010, following 1 year and 9 months as CRA I/CRA II in WWCT. My therapeutic experience includes phases II and III adult trials. Since March 2010, I’ve been responsible for monitoring activities in more than 30 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.
Senior Clinical Research Associate, PAREXEL International RUS, Saint-Petersburg, Russia, November 2011 - April 2016
- Perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), 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.
Clinical Research Associate II, PAREXEL International RUS, Saint-Petersburg, Russia, March 2010 – November 2011
- Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL and Sponsor’s Standard Operating Procedures (SOPs).
- Responsible for achieving and maintaining high site performance, managing clinical monitoring activities which include the ownership of investigator sites, the selection of investigator/sites, collecting Regulatory Documentation, selecting, initiating and monitoring of sites, performing site documentation verification, data collection and drug accountability in accordance with ICH GCP guidelines.
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
- Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance to Good Clinical Practice (GCP) and applicable local and international regulations and SOPs.
- Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
Chief of Medical Service, Military Forces of Russian Federation, Russia, April 2006 – May 2008
- Responsibilities - according to JD.
Senior Laboratory Assistant, Department of Clinical Laboratory Diagnostics, I. P. Pavlov Saint-Petersburg State Medical University, Saint-Petersburg, Russia, October 2005 – April 2006
- Fulfill clinical laboratory diagnostics tests, scientific and organizational tasks.
- 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