Evgeniy Bashlakov

Experience

• 

  PSI Co Ltd

  Jan 2007 - Feb 2010

  Clinical Research Associate

  • Qualification (Selection), Initiation, Interim and Closeout monitoring visits performance.• Monitoring the conduct of clinical trials, especially enrollment and quality of data.• Thorough checking CRF against source documentation.• Verification subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.• Appropriate, accurate and timely Adverse Events reporting and of necessary follow-up activities as needed.• Ensuring accurate study drug storage and dispense.• Organisation of Study Trial Master File (TMF)• Business trips and related expenses management with following reporting.• Queries resolution.• Managing site master file contents and working with sites to ensure communication requirements between site and IRB are adhered. • Assistance during on-site audits• Providing the conduct of successful site audits and timely follow-up for all quality assurance activities.• Sites instruction on maintenance of an IVRS/IWRS and EDC.• Acquiring specific clinical and therapeutic knowledge related to studies monitored. • Conducting feasibility with a following high percent of site enrollment (primary contact with potential investigator sites).• Conduct of investigator meetings both in English and in Russian• Promotion of patient recruitment• Performing all duties as assigned by the Project Manager. Show less

• 

  Outpatient clinic

  Feb 2010 - Sept 2013

  • Arranged and managed a new department in the outpatient clinic;• Reached milestones set by the Healthcare Committee;• Reported to both regulatory authorities and the head physician on weekly and monthly basis;• Educates patients on wellness, prevention and early detection by providing materials and resources to patients and their families;• Provided advice to patients and staff regarding disease prevention and health promotion; • Instructed, guided, and supervised junior medical staff (9 persons);• Suggested new initiatives to assist in providing effective medical services. Show less • Diagnosed patients, ordered diagnostic tests and provided referrals for specialized treatment or rehabilitation;• Accurately conducted wellness exams and provided treatment medical care for individuals spanning variety of indications: urology, oncology, neurology, therapeutics, rehabilitation after surgical intervention, gastroenterology, rheumatology;• Managed appropriately outpatients and admitted them when necessary;• Took care and advised the patients referred by other hospital specialist colleagues;• Ensured that patients understand all treatments and procedures while providing health care;• Maintained effective relationships with patients while dealing with them;• Ensured the accurate maintenance of comprehensive medical records for in and out patients;• Managed administrative staff and a long list of regular patients;• Collaborated with clinical staff and specialty physicians on multiple discipline treatments and coordinated care efforts;• Strong knowledge of relevant drugs, chemical compositions and substance properties;• Worked irregular hours. Show less

  • Head of the Preventive Medicine Department

    May 2013 - Sept 2013

  • Physician

    Feb 2010 - Sept 2013
• 

  Parexel

  Sept 2013 - now

  • Manages study start-up activities• Provides input to project tools, PL project plan, Central File Maintenance Plan, the format and content for sponsor reports and oversees the site selection strategy plan• Develops site selection and monitoring plans for the team• Reviews and provides input into patient recruitment plan and retention plan• Ensures all team members have access to tools and documents• Establishes efficient working relationships with other functional Leaders and coordinators within a given program• Develops study plans, tools and forms.• Provides leadership and direction to project team members• Identifies, organizes and delivers study specific training• Evaluates and identify resourcing needs and continuously monitor over life cycle of project• Provides productivity targets to project team members• Provides performance feedback on team members as appropriate• Addresses identified and escalated site issues and drives to closure• Early recognizes areas of potential problems and provides input to mitigation plans• Monitors study timelines, patient recruitment, retention and data cleaning to ensure successfuloutcome of the project• Oversees maintenance and quality check of Central Files• Maintains and assures quality of work generated and escalates and follows up as appropriate• Implements and initiates process improvements within the project• Identifies changes in scope and liaises with Project Leader• Participates in client, investigator and team meetings• Prepares, participates in and follow up on audits / inspections• Collaborates with project team on database lock activities• Together with Project Leader ensures all administrative closeout procedures are completed, project is archived and all documentation returned to the client as specified by the contract• Maintains a working knowledge and ensure compliance with ICH-GCP, applicable local regulations and SOPs, Operational Guidelines, study specific procedure Show less - Oncology: SCLC, NSCLC, Breast cancer, CRC- Skin purulent infection- Rheumatoid arthritis- Diabetes Mellitus- Osteoporosis in postmenopausal subjects- Axial Spondyloarthritis- SLE (Lupus nephritis)• Coordinates a moderate to large team or multiple small size protocols as the CRA Coordinator, with minimal to no supervision;• Represents function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent PAREXEL at professional meetings/conferences;• Functions as mentor an role model for other CRA team members to ensure study specific training for CRAs;• Performs co-monitoring visits with less experienced CRAs or at problem sites as required;• Conducts the clinical monitoring aspect of designated projects;• Performs clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection);• Performs qualification, initiation, monitoring and termination of investigational sites;• Arranges on-site visits and logistics (e.g. travel arrangements) Show less

  • Senior Clinical Operations Lead

    Jan 2022 - now

  • Clinical Operations Lead

    May 2016 - Dec 2021

  • Senior CRA

    Sept 2013 - May 2016