Clinical Research Associate (CRA)
Let's explore the responsibilities of this role.
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What Does a Clinical Research Associate Do?
The expectations from your Manager includes having an in depth understanding of ICH-GCP (International Conference on Harmonisation – Good Clinical Practice) . ICH-GCP are a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public. It is the most important aspect of your role in managing clinical trials.
In your role as a CRA, you will be required to:
- Maintain a high level of training and procedural guidance regarding the company wide clinical trial programs
- Contribute to the development and implementation of the clinical trial programs in your therapeutic area
- Ensure smooth management of your clinical trials program from set up to completion
- Act as an expert/resource for internal and external stakeholders relating to your allocated clinical trials
- Engage in peer-to-peer level dialogue with key stakeholders in relation to your study. This will include research leads in the hospitals, CRO project manager and investigators
- Establishing relationships with key stakeholders to educate and ensure awareness of clinical trial activity within the company
- Providing internal stakeholders with information collected regarding your clinical trials
- Review of all clinical trial studies to ensure correct audit compliance and adverse event reporting
- Adherence to internal processes and external regulations including the relevant Code of Conduct to meet internal SOP and local regulations
