Essential training for a new CRA or those interested in a CRA role
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.
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 CRA's role
Those that do not have a clinical trial background who are seeking to broaden their understanding of the role of the CRA
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
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
Anna Megalakakis
Anna is a seasoned professional with over two decades of experience in the Contract Research Organization (CRO) and pharmaceutical industry. As a Senior Training Manager, Anna has dedicated her career to cultivating excellence and expertise in the pharmaceutical field, playing a pivotal role in shaping the knowledge and skills of industry professionals. Anna's journey in the pharmaceutical sector began after she completed her studies from Monash University. Her fascination with human health propelled her into the dynamic world of clinical research. Over the years, Anna has held various roles in clinical operations, and training, gaining invaluable insights into the complexities of drug development and regulatory compliance. Passionate about education, Anna recognized the importance of continuous learning and professional development in an ever-evolving industry. Drawing upon her wealth of experience, she transitioned into the role of senior training manager at ARCS, where she could leverage her expertise to empower and inspire the next generation of pharmaceutical professionals.
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.
ARCS Member - $1415
Non-member - $2275
Two-day training
This workshop runs for two days from 10:00-16:00 AEST
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