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.