SKILLED Clinical Trial Administrative Officer Internship

Cohort

• Science based Honours graduates or higher

Internship program

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

Orientation program – 1 week

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-site supervised training 

Develop practical skills

• Supervised to develop CTA skill-set
• Competence assessed 

Site improvement project

Using their research skills and in consultation with the host site interns identify, implement, present and report on a quality or efficiency improvement at their site.

Additional training

• TransCelerate accredited Good Clinical Practice (GCP) workshop: Peter MacCallum Cancer Centre
• Cancer Trials Australia - Introductory & Advanced Budgeting, Contracts and Ethics Submissions workshop
• Safe Transport of Infectious Substances by Air Course: Civil Aviation Academy Australasia Pty Ltd
• Paediatric Clinical Trials: The Royal Children's Hospital
• Role of the ETHICS office: Murdoch Children's Research Institute
• ERM hands on workshop
• Royal Children’s Hospital - Paediatric Clinical Trials and Governance workshop

“Clinical Trial Assistant (CTA) Competency Framework” by Australian Clinical Trials Education Centre (A-CTEC) is used under the CC BY-NC-SA 4.0 licence. Modifications to this framework include presenting the competencies in diagram form.

Acknowledgements

The VCCC Alliance SKILLED program is in partnership with Parkville Cancer Clinical Trials Unit (PCCTU), Deakin University, Monash University, La Trobe University and the University of Melbourne. The 2025 SKILLED Clinical Trials Internship program is supported by the Victorian Government.