SKILLED Clinical Trial Assistant 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 & in consultation with the host site interns identify, implement, present & 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

Acknowledgements

The SKILLED Clinical Trials Internships program partnership falls under MTPConnect’s $32 million Researcher Exchange and Development within Industry (REDI) initiative made possible by the Medical Research Future Fund, providing industry experiences and skills development for early and mid-career researchers, clinicians and innovators to develop an industry-ready workforce keeping pace with the demands of a rapidly changing sector.

The Bringing SKILLED interns to the Regions Project is supported by the Victorian State Government Department of Jobs, Precincts and Regions.