Virtual workshop
Clinical Trials 101 virtual workshop series
Knowledge can fade over time. This means most of us must occasionally revisit and review important concepts. Refresher training helps keep key knowledge up to date.
That’s why we developed a 2 part workshop series that cover the fundamentals of clinical trials.
Clinical Trials 101 covers several key topics into two sessions to provide you with the fundamental knowledge to work in the sector.
This interactive workshop series aims to strengthen your understanding of clinical trials, including steps to plan, conduct and evaluate trials and meet regulatory requirements.
Who is this workshop for?
We have seen a diverse range of research professionals enrol into Clinical Trials 101:
- Clinical Trial Coordinators,
- Clinical Trial Managers,
- Early-career research/clinical trial staff,
- Research Managers,
- HREC Officers,
- Project Officers,
- those new to clinical trials.
Regardless of your experience, Clinical Trials 101 can provide value and help you take your career to new heights.
Parts 1 and 2 are stand-alone and priced separately. You can choose to do just one, or both as a complete set.
You can claim 3 CPD points from each workshop.
Part 1: The Australian Landscape
Part 1 covers:
- Trial types – phases, commercial and non-commercial, investigator-initiated, first in human and terminology
- Good Clinical Practice (GCP)
- Roles, and responsibilities of stakeholders
- Regulation
- Ethics
- Governance and navigating regulatory requirements
- The critical role of project planning – project and organisational-wide considerations
- Consumer priorities
Part 2: Feasibility and Start-up
Part 2 covers:
- The start-up process
- Resourcing (people, process, infrastructure)
- Recruitment
- Budgets
- Identifying barriers to efficient start-up
- The feasibility process
What will you learn?
On completion, you will:
- Be able to define the different trial types
- Understand Good Clinical Practice and its purpose in clinical trials to ensure participant safety and data integrity
- Know your roles and responsibilities in clinical trials to avoid risk and excel in your role
- Understand research ethics and governance and how it applies to your work
- Be able to confidently navigate regulatory requirements to ensure you are compliant
- Know how to successfully recruit for your next clinical trial to avoid delays or early termination
- Be able to set an effective budget for a clinical trial to maximise your finances
Facilitator
Michelle Tusler
Michelle is a clinical research professional with 15+ years’ experience in multiple clinical research roles within pharmaceutical companies and CROs with national and international project management experience.
Currently the Head of Clinical Operations at an Australian based CRO, Michelle specialises in supporting small to medium biotech companies in their drug development pathway.
Passionate about quality training and oversight management for Sponsors and also Site Responsibilities, Michelle has implemented major Clinical Trial Management Systems (CTMS) and been part of Risk Based Monitoring development across multiple companies.
Michelle is a qualified auditor in ISO 9001:2015 and has a keen interest in developing quality systems in relation to delivering clinical research to a high standard.
Price
Part 1: $599pp + GST
Part 2: $599pp + GST
Complete package (part 1 and part 2: $1199 + GST)
*Savings available for group enrolments and for PRAXIS partner organisations.
Times below are Sydney/Canberra/Melbourne time.
Next Virtual Workshops
PART 1 – Tuesday 12 November 2024: 10.00am – 14.00pm
PART 2 – Wednesday 20 November 2024: 10.00am – 14.00pm
Please note part 1 and 2 are stand alone workshops and require separate enrolments.
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions document.
Our training and education offers have been developed according to Australian and international best practice standards.
Our modules are built upon the competencies developed by the Harvard Multi-Regional Trials Centre (MRCT) and aligned to competencies recommended by the NHMRC.
These training offers are regarded as a benchmark for researchers, clinical trials, and healthcare professionals in Australia and internationally.
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.