Igor Lipkin
South San Francisco,CA
Summary
Knowledgeable Clinical Research Associate with several years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Overview
27
27
years of professional experience
Work History
Sr. Clinical Research Associate - Contract
Advanced Concepts Consulting
San Francisco, CA
08.2018 - Current
- Monitored and supported the activities at the clinical trial sites to recruit and enroll study participants
- Ensured data quality and follow up with site coordinator on the data input of the clinical data capture into electronic data systems
- Responsible for completion of visit reports and maintenance of study-related databases
- Ensure site’s submission of Essential documents to the eTMF
- Managed the communications with the site staff on patient recruitment activities and coordinate patient visits and procedures related to clinical research
- Acted as a resource for study sites and participants by answering questions and explaining related procedures
- Ensured the study site is compliant with all local and federal laws and regulations
- Monitored study sites and activities to ensure the appropriate industry protocols and terms of the study are being followed
- Participated in the hiring and training of staff members who are working on the study both on ICH GCP and on protocol related materials
- Created thorough documentation of study protocol and updated it as needed.
Software Engineer
Kaiser Permanente
Pleasanton, CA
05.2016 - 07.2018
- Effectively led and coordinated testing efforts for high-visibility projects to contribute to the overall success and demonstrated the value of thorough testing in achieving project goals
- Actively participated in the Agile ceremonies and practices
- Contributed to the success of the Agile Release Train by promoting collaboration, transparency, and the continuous delivery of value
- Effectively utilized JIRA, Jenkins, Power BI and Confluence tools to support the entire software development lifecycle
- Successfully led and managed activities of Managed Deliverable (MD) automation testing teams
- Facilitated and actively participated in project planning, features, user stories, tasks and defects review meetings
- Organized training sessions with diverse cross-section of stakeholders, application consultants, development and testing team members
- Incorporated clinical content and deliverables into system and functional testing
- Managed critical information that directly impacted various aspects of software functionality
- Led cross-training within the team to ensure that members have a broad understanding of various aspects of the project.
Sr. QA Tester - Technical Lead
Kaiser Permanente
Emeryville and Pleasanton, CA
01.2009 - 01.2016
- Coordinated test strategy development and planning meetings
- Facilitated discussions and acted as a liaison between multiple teams
- Led defect management process
- Built and managed the team of “new resources” into a qualified team of QA Testers
- Recognized by the Leadership for contributions to the team and ability to guide, inspire, and achieve positive results
- Coordinated and participated in design and development of comprehensive set of test suites
- Processed HL7 (Health Level Seven) messages.
Sr. QA Tester, Analyst
Kaiser Permanente
Oakland and Emeryville, CA
01.2006 - 01.2009
- Successfully led and co-led small, medium and large testing engagements
- Provided training and support on AACC/Stargate, VMM applications
- Worked closely with clinical subject matter experts
- Developed test scenarios and test cases
- Supported production releases
- Effectively managed and mentored a functional test team
- Provided knowledge transfer of major logistics, functionality and security
- Facilitated communication among all parties accountable for defect resolution.
Sr. QA Tester
Kaiser Permanente
Oakland, CA
01.1999 - 01.2006
- Performed and assisted in acceptance, integration, end-to-end, and regression testing
- Designed test scenarios and test cases
- Provided technical assistance for PARRS Appointment booking, PCP and CIPS/CDR data creation and validation
- Integrated regression testing into continuous integration pipelines
- Organized and delivered comprehensive test result reports.
Consultant Test Analyst (Contractor)
Kaiser Permanente
Oakland, CA
01.1997 - 01.1999
- Performed unit, system, integrity and regression testing of application
- Responsible for the test data set up and promoting new code to QA team
- Responsible for the test cases development and testing for AACC/Stargate application
- Provided production support to ensure the stability, reliability, and continuous operation of software systems in a live environment.
Education
Barnett International Training and Certificate for CRA and CRC -
CITI Training, GCP Certificate -
Advanced Business Computer Systems and Information course - School for Business and Technology (Wind - Apple), San Francisco, CA -
B.S. in Chemistry and Mechanical Engineering - Institute of Chemical and Mechanical Engineering -
Skills
- ACRP Certified
- EDC - Medrio, Axiom, Datatrack
- eTMF and CTMs - Veeva Vault and Simple Trials
- Site Monitoring
- IRB regulations and submissions
- Conducting SQV, SIV and COV
- Data Entry
- Analytical
- Attention to Detail
- Data Management
- Flexible and Adaptable
Timeline
Sr. Clinical Research Associate - Contract
Advanced Concepts Consulting
08.2018 - Current
Software Engineer
Kaiser Permanente
05.2016 - 07.2018
Sr. QA Tester - Technical Lead
Kaiser Permanente
01.2009 - 01.2016
Sr. QA Tester, Analyst
Kaiser Permanente
01.2006 - 01.2009
Sr. QA Tester
Kaiser Permanente
01.1999 - 01.2006
Consultant Test Analyst (Contractor)
Kaiser Permanente
01.1997 - 01.1999
Barnett International Training and Certificate for CRA and CRC -
CITI Training, GCP Certificate -
Advanced Business Computer Systems and Information course - School for Business and Technology (Wind - Apple), San Francisco, CA -
B.S. in Chemistry and Mechanical Engineering - Institute of Chemical and Mechanical Engineering -
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