Clinical Research Associate (CRA) Training Course

Course Overview

This two-day introductory course covers the current regulatory environment and drug development process with an aim to guide Clinical Research Associates (CRAs) through their role conducting studies in Australia and New Zealand. The curriculum offers a foundation in all significant areas relevant to establishing and running clinical trials.

Course Highlights

Day 1  Beginning with a consideration of the wider medical, ethical and regulatory framework in which studies are conducted, areas covered include:

  • Therapeutic goods and their regulation
  • Drug development and the clinical trial process
  • Good Clinical Practice (GCP) – Guidelines from the ICH, WHO and others
  • Declaration of Helsinki – Protocol review (research ethics and governance)

Day 2  This session shifts focus to the practical aspects of setting up and running a study, with attendees to engage in hands-on problem solving. Topics to be covered include:

  • Starting out
  • Study site selection and evaluation
  • The role of the CRA
  • Monitoring visits
  • Adverse events and safety monitoring
  • Study initiation and close-out visits
  • Useful tools, checklists and forms
  • Data clarification
  • Forming good on-site relationships
  • Audits and inspections

Who Should Attend

  • New CRAs needing information about their roles, tasks and responsibilities
  • Current hospital/clinic workers needing a better understanding of the CRA’s role
  • Those without a clinical background seeking to learn about the duties of CRAs

Course Fees (incl. GST)

Students – $850.00 Non-students – $1500.00