TGI is committed to developing the leadership skills of our team leaders to ensure they are equipped to manage their direct reports in all situations.
At the end of this course you will
• be aware of and be able to apply the relevant policies relating to line management in The George Insitute
• Understand how to use THRIVE to set and oversee goals of your direct reports
• Understand the recruitment process in TGI
The George Institute for Global Health is committed to developing the leadership skills of our team leaders to ensure they are equipped to manage their direct reports in all situations.
At the end of this course you will
• be aware of and be able to apply the relevant policies relating to line management in TGI
• Understand how to use THRIVE to set and oversee goals of your direct reports
• Understand the recruitment process in TGI.
At the end of this training course, you will understand the role and responsibilities required of a Project Officer.
At the end of this training course, you will understand the role and responsibilities required of a Project Manager.
By the end of this course, you will be:
- Able to identify the appropriate database to use in a project based on study design and data requirements.
- Understand the role and responsibilities of a project manager and activities required at during a project’s lifecycle.
- Understand the reasons for registering projects on public databases, what information needs to be included, when information should be updated, and which database to register a project on.
- Understand the sponsor’s responsibilities for managing safety reports once they arrive from sites.
- Understand the difference between Significant Safety Issues and Urgent Safety Measures and the reporting timelines required for these events.
- Apply CAPA Principles to manage any type of issue that arises during a project.
- Understand the principles of data management, and the roles and responsibilities of project managers in ensuring clean database is delivered efficiently and on time.
- Understand when it is appropriate or not to delegate tasks to others.
At the end of this training course, you will understand the general role and responsibilities required of a Clinical Research Assistant (CRA).
By the end of this training, you will be able to:
- Understand how to prepare, conduct and report on monitoring activities.
- Understand the reasons for registering projects on public databases, what information needs to be included, when information should be updated, and which database to register a project on.
- Understand the sponsor’s responsibilities for managing safety reports once they arrive from sites.
- Understand the difference between Significant Safety Issues and Urgent Safety Measures and the reporting timelines required for these events.
- Apply CAPA Principles to manage any type of issue that arises during a project.
- Understand the principles of data management, and the roles and responsibilities of CRAs in ensuring data is entered and queries raised and closed in a timely manner to ensure delivery of good quality database.
- Understand when it is appropriate or not to delegate tasks to others.
At the end of this training course you will have an understanding of common tasks required of a Clinical trial coordinator (CTC), how and when to perform those tasks.
1. Understand how to prepare for a monitoring visit, what to expect during a monitoring visit and how to work effectively with a monitor.
2. Apply principles of issue and CAPA Management to address quality issues identified at site.
3. Define source documentation and understand the difference and importance of source. documents and CRFs and identify when certified copies of source documents are required.
4. Understand the reasons behind timely data entry.
5. Awareness of different EDC requirements.
6. Understand and apply principles of IMP management at site.
7. Understand and apply the concepts of effective delegation.
8. Describe the typical tasks of a CTC at TGI.
At the end of this training course you will have an understanding of common tasks required of a Clinical Trial Assistant (CTA), how and when to perform those tasks.
1. Understand the processes for submitting invoices for payment via the finance system.
2. Able to support APO staff with purchasing requests.
3. Define source documentation and understand the difference and importance of source documents and CRFs.
4. Understand the reasons behind timely data entry.
5. Understand the typical tasks of a CTA/PA at TGI.
At the end of this training course you will have an understanding of the fundamental requirements of conducting research studies according to principals of ICH GCP.
Intended learning objectives:
- Understand and apply the principles of ICH GCP (GCP)
- Understand the purpose and conduct of clinical research studies. (Intro to Clinical Research)
- Understand the processes for obtaining ethical and regulatory approvals for human research studies and drug trials in Australia
- Understand and apply the principles of obtaining and documenting participant informed consent. (Informed Consent)
- Understand, identify and track essential documents required throughout the conduct of a research study (Essential Documents)
- Understand the principles of monitoring activities, identify the different methods of monitoring and apply a risk-based approach to performing monitoring tasks. (Monitoring)
- Create appropriate tracking tools to assist in the management and oversight of clinical research studies. (Setting up and maintaining trackers)
- Improve communication skills required to effectively perform tasks and oversee activities during the conduct of clinical research studies. (Effective Communication)
- Initiate, organize, conduct and appropriately minute meetings required for the oversight and conduct of clinical research (Meeting Management)
- Apply principles of time management to enhance productivity. (Time Management)
- Develop skills to engage effectively with stakeholders to deliver study outcomes. (Influencing People)