Start Date

20 March 2023

End Date

21 March 2023

Start Time

09:00

End Time

17:00

Venue

ARCS Virtual Classroom

Who Can Register?

Anyone

Essential training for a new CRA or those interested in a CRA role.

Workshop overview

Do you have questions about the role of the Clinical Research Associate (CRA) in clinical research? Do you need a good solid foundation in GCP? This introductory workshop covers the current regulatory environment, drug development process and guides CRAs through their role in conducting studies in Australia and New Zealand. It will give you a solid introduction to the major areas to consider when conducting clinical research. It is essential training for a new CRA.

Who should attend

The workshop is aimed at:

• New CRAs who need more information about the typical roles, tasks and responsibilities of CRAs

• Site personnel with experience in clinical research, interested in a better understanding of the CRAs role

• Those that do not have a clinical trial background who are seeking to broaden their understanding of the role of the CRA

Workshop highlights

Day 1

• Therapeutic goods and their regulation

• Access to unapproved therapeutic goods

• The drug development process

  • The big picture

  • The clinical trial process

• GCP (ICH, WHO and others)

  • Declaration of Helsinki

• Protocol Review

Day 2

• Getting a study started:

  • Site selection

  • Ethical review of research and Research Governance

• Monitoring

  • The whole story

  • The role of the CRA

  • Monitoring - what is it?

  • Useful tools, checklists & forms

  • Data clarification

  • Hands on experience!

  • SDV exercise

• Study Closure, Audits and Inspections

Speaker Bio

Sue Mason

Sue Mason is an Education Manager at ARCS Australia. Sue has over 20 years’ experience in clinical research and is responsible for educational support for members and stakeholders through the development, management and delivery of education in clinical research. Sue is the ARCS contact for the Interest Areas related to clinical sites and monitoring, medical information, MSLs as well as the regional area groups.

Continuing Professional Development (CPD) points

Upon completion of this workshop, attendees will receive 14 CPD points.

Entry criteria

This is an entry level/introductory workshop. There are no entry criteria for this workshop. If you have any questions on your suitability for this workshop, please contact the ARCS office on (02) 8905 0829.

Registration fees

Workshop fees (incl. GST) 
Early bird - until 20 Feb
ARCS Member - $940.00
Retired/Student Member - $695.00 
Non Member - $1560.00 

Standard - from 21 Feb
ARCS Member - $1250.00 
Retired/Student Member - $940.00 
Non Member - $2025.00

Two-day training

This workshop runs for two full days from 09:00-17:00 AEDT