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
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, 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
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.