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
• 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.