SKILLED Clinical Trial Assistant Internship

Cohort

  • BSc (Hons) or higher

Internship program

  • Intensive, accelerated learning
  • Developed and run in collaboration with Parkville Cancer Clinical Trial Unit
    • 24-week program
    • 2-week orientation
    • Competency based training

Orientation program – 2 weeks

Knowledge

  • An introduction to clinical trials
  • Running a clinical trial from A-Z
  • The regulatory environment of clinical trials
  • Ethics and governance submissions
  • Safety reporting in clinical trials
  • Monitoring and auditing clinical trials

Practical skills

  • Trial related communications/coordination
  • Software/databases used in trials
  • Managing study files
  • Data management and patient confidentiality
  • Post-approval reporting (the role of a clinical trial assistant)
  • Effective communication with monitors
  • Site initiation visits (SIVs) from a monitor’s perspective
  • Site monitoring visits
  • Site file workshop
  • Archiving workshop

On-the-job supervised training – 22 weeks

Develop practical skills

  • Supervised to develop CTA skill-set
  • Competence assessed (weeks 11 and 23)

Site improvement project

Interns identify and implement a quality or efficiency improvement at their site.

Additional training

  • TransCelerate accredited Good Clinical Practice (GCP) workshop: Peter MacCallum Cancer Centre
  • Interpreting protocols, ethics applications, patient informed consent, negotiation skills workshop: Cancer Trials Australia
  • Safe Transport of Infectious Substances by Air Course: 2019 Civil Aviation Academy Australasia Pty Ltd

Competencies framework chart