SKILLED Study Coordinator Internship

Cohort

  • PhD under submission

Internship program

  • Intensive, accelerated learning
  • Developed and run in collaboration with Parkville Cancer Clinical Trial Unit
    • 40-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
  • Good Clinical Practice (GCP) training

Practical skills

  • Trial related communications/coordination
  • Software/databases used in trials
  • Mastering your protocol workshop
  • Site file workshop
  • Data management and patient confidentiality
  • Post-approval reporting (the role of a site coordinator)
  • Effective communication with monitors
  • Site initiation visits (SIVs) from a monitor’s perspective
  • Patient management – attend clinics
  • Preparing for site monitoring visits
  • Trial kits management
  • Tumor assessments (RECIST and non-solid disease assessment)
  • Common Terminology Criteria for Adverse Events (CTCAE)

On-the-job supervised training – 38 weeks

Develop practical skills

  • Supervised to develop study coordinator skill-set
  • Competence assessed (weeks 15, 25 and 37)

Site improvement project

Using their research skills, 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
  • Cancer Trials Australia workshop: Interpreting protocols, ethics applications, patient informed consent, negotiation skills workshop: Cancer Trials Australia
  • Introduction to cancer – Overview of cancer epidemiology, cell physiology, carcinogenesis, treatment options and the impact of cancer on patients: Peter MacCallum Cancer Centre
  • Managing difficult conversations about cancer with patients and their families workshop: Cancer Council Victoria
  • Safe Transport of Infectious Substances by Air Course: 2019 Civil Aviation Academy Australasia Pty Ltd
  • Online Clinical Research Coordinator Training: Advantage Clinical

Competencies framework chart