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Clinical Trial Site Coordination (CLRS90022)
Graduate courseworkPoints: 12.5Not available in 2018
Overview
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In this subject, students will select a minimum of 10 hours of electives depending on their needs plus a compulsory capstone component.
Electives (minimum of 10 hours of teaching).
• Assertiveness in the workplace (7 hours) or Managing and Resolving Conflict (7 hours)
• Fundamentals of project management (7 hours)
• Statistics for non-statisticians (14 hours)
• Managing laboratories in clinical research (14 hours)
• Effective management of GCP issues (3 hours)
• Introduction to pharmacovigilance (3 hours)
• Research ethics and governance (3 hours)
Capstone
• Coordinating single and multi-centre clinical research more effectively (14 hours)
Intended learning outcomes
Students who successfully complete this subject should:
- Understand how to effectively coordinate research activities at a clinical research site
- Understand and manage risk at a clinical research site
- Understand the role of project management in good clinical practice
- Be able to provide input in the implementation of clinical research studies within Australia
- Understand the purpose and operational responsibilities of a Clinical Research Associate in maintaining the quality standards defined by Australian legislation and Good Clinical Practice
Last updated: 3 November 2022