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This course covers skills a CRA Manager needs to oversee a clinical project and includes the more advanced aspects of site and monitoring oversight from a quality system approach. Topics include designing a clinical study protocol, statistical considerations, how to identify and manage effective clinical investigators including designing site questionnaires specific to your protocol, what to look for when conducting your pre-qualification visits, type of questions to ask during those visits and comparing potential sites. Practical methods on how to summarize site findings and provide site recommendations to upper management and how to assess and train sites to meet study protocol and applicable regulations will be discussed

Additional topics include how to assess the most effective monitoring strategy based on a clinical quality system approach, application of risk management and quality assurance, closed-loop monitoring, detecting fraudulent data, and escalation of issues. The course will also cover soft skills required for a CRA manager including time management, communication skills, training and motivation skills


  • Define and differentiate between Sponsor and Investigative Site responsibilities under ICH E6 Good Clinical Practices
  • Define the concepts of a Clinical Quality System Approach
  • Define the principals of a risk management approach to study conduct
  • Define and demonstrate the application of risk management tools to study conduct
  • Identify Quality Assurance steps for a clinical program
  • Demonstrate use of a risk management approach in compliance issues management and audit readiness
  • Understand the different audit tools
  • Define the steps followed for preparing and follow-up of an FDA Inspection
  • Understand the role of project management, including management of Investigative Sites and Sponsor’s Clinical Research Professionals
  • Acquire Management Soft skill like communication and Motivation of fellow CRAs



  • Clinical Research Coordinators/Associates looking to move on to management level
  • Clinical Research professionals
  • Clinical Scientist / Basic Scientist
  • Clinical Investigators / Principal Investigators
  • Experienced Clinical Quality Assurance Professionals
  • Project Managers
  • Clinical Study Coordinators
  • Regulatory Affairs Professionals