This is an intermediate workshop that seeks to build on topics covered during the first workshop titled “Essential and Practical GCP Training for New Monitors and CRAs”.
This is an intermediate workshop that seeks to build on topics covered during the first workshop titled “Essential and Practical GCP Training for New Monitors and CRAs”. It will help improve your site management skills by starting with a high level review of the ABCs of project management. The workshop then covers a number of challenges and strategies to effectively manage risk within key clinical trial processes and to assist you to get the most from your trial sites.
Individuals with 12 months or more experience implementing clinical research looking to develop better site management skills
Experienced monitors looking to move into more senior positions
Individuals looking for a forum to discuss how different people tackle typical problems encountered when implementing clinical trials
Day 1
Review of research standards
The ABCs of clinical trial project management
The role of the project manager
The project trade-offs
Ten critical considerations when planning your next clinical trial
Project reporting
Project risk
How to managing risk via effective:
Feasibility assessments
Site selection
Informed consent process
Day 2
How to managing risk via effective (continued):
Recruitment strategies and contingencies
Investigational product (IP) management
Supporting your sites with effective communication and motivating the team
Quality Management
Managing GCP issue more effectively
Fraud and misconduct
Common audit issues
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:
To get the most out of this workshop, you should have at least 12 months experience implementing and monitoring clinical research. The workshop assumes you have an understanding of the clinical trial process, relevant regulations and ICH-GCP. If you have any questions on your suitability for this workshop, do not hesitate to call the ARCS office on (02) 8905 0829.
Early bird - until 9 Feb
ARCS Member - $915.00
Retired/Student Member - $675.00
Non Member - $1520.00
Standard - from 10 Feb
ARCS Member - $1215.00
Retired/Student Member - $915.00
Non Member - $1975.00
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