Clinical Research Associate (CRA)
Entry Guidelines and Judging Criteria
This category is designed to challenge the CRA’s understanding of the core aspects of patient safety and data integrity through rigorous site monitoring, and management. Your understanding of the CRA role, from developing of a monitoring plan, execution of the study conducts to the close out of the study at a site level will be tested.
Suitable for experienced CRAs with 1+ years site monitoring and management experience.
* Finalists will be invited to take part in category-specific case-study challenges developed by an independent expert panel.
* Finalists will be presented with the ‘live’ challenge on arrival at the finals day, where given a set period of time for preparation (max 1 hour) – before delivering their response to a judging panel of senior marketing and industry leaders.
Specific scoring criteria will be developed alongside each year’s unique case-study / challenge. As well as understanding the case study and challenges, CRA finalists will be expected to demonstrate the following core CRA skills:
- Ability to define the core strategic challenge
- Ability to assimilate the study protocol information for quality site management of patient safety and data integrity.
- Show ability to analyse the data available
- Knowledge and application of site monitoring
- Demonstrate ability to identify issues, action items with the ability to work to their resolution considering other study team members / site staff involved. Develop solutions and implement plans
- Show high quality ability to perform Risk Based Monitoring and know the key drivers