Developed and run in collaboration with Parkville Cancer Clinical Trial Unit
40-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
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
Tumour assessments (RECIST and non-solid disease assessment)
Common Terminology Criteria for Adverse Events (CTCAE)
On-site supervised training
Develop practical skills
Supervised to develop study coordinator 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
Introduction to cancer – Overview of cancer epidemiology, cell physiology, carcinogenesis, treatment options and the impact of cancer on patients: Peter MacCallum Cancer Centre
Responding to Emotions in Cancer workshop: Cancer Council Victoria
Safe Transport of Infectious Substances by Air Course: Civil Aviation Academy Australasia Pty Ltd
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 Victoria State Government Department of Jobs, Precincts and Regions.