Introduction

Clinical research is a complex and highly regulated field that relies on the coordination and expertise of many professionals. Among them are Study Coordinators who play a pivotal role in ensuring the success of clinical trials from patient recruitment and data collection to compliance and communication with sponsors and regulatory bodies.

The “Study Coordinator Toolkit” is designed as a comprehensive resource for both new and experienced coordinators. It offers quick access to essential tools, key information, and best practices that support efficient, ethical, and high-quality research operations.

Whether you’re managing your first study or juggling multiple trials, this toolkit will help you confidently find the resources you need, streamline your workflow, and strengthen your capabilities in this critical role.

If you would like to add a resource you find useful and not listed here, or have any questions, please contact Heshani Nesfield at Heshani.nesfield@anzgog.org.au

Resources

ACTEC – Australian Clinical Trial Education Centre

  • Supporting high-quality clinical trial conduct in Australia by providing education, training, and resources to the clinical trials workforce. Free education including:
    • Online courses
    • GCP
    • Webinars
    • Competency Frameworks
    • Investigator & Research Staff Training Modules
    • Site Resources Hub

International Council for Harmonisation (ICH) guideline for Good Clinical Practice – The Guideline for Good Clinical Practice is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The Guideline for Good Clinical Practice is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the Guideline is a condition of approval for the conduct of a clinical trial.

Site Management Modules – Society for Clinical Research Sites – Informational programs for site staff (SCRS membership required)

IATA Training

RETProgram – Research Education & Training – Courses incl. Intro to Health Research, GCP Refresher, Consumer Involvement, Grant Writing, Health Economics, Protocol Writing

NZACRes – Regulations and trial documentation templates (membership required)

National Statement on Ethical Conduct in Human Research

  • The National Statement has been produced by the NHMRC as the Australian ethical standard against which all research involving humans, including clinical trials, are reviewed. The National Statement is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the National Statement is a condition of approval for the conduct of a clinical trial.
  • If requirements specified in the National Statement appear to differ from those specified in the Guideline for Good Clinical Practice, the TGA recommends compliance with the National Statement.