A day in the life of a CRA

When it comes to the “life of a CRA” we must differentiate between a regular office day and an onsite day.

When CRAs have one of their office days the first thing they will do is most likely following up on all the email requests that came in during their last monitoring visit and were not urgent or related to patient safety so that it’s okay to follow up on them when the CRA is back in the office. This might be site requests as they need clarification for the protocol, support to order investigational product or supplies or clarification on queries related to their data but also status updates the CRA must provide to the clinical team lead or sponsor which often includes updates of electronic systems or excel trackers. There might be questions about issue resolution progress or information related to the study lifecycle and patient recruitment.?

When the CRA checked the emails and prioritized the most important tasks for further follow up it is the right time to plan the next upcoming monitoring visit. This is not limited to the confirmation of the visit with the site and making the required arrangements for the business trip like booking the flight, the train tickets, or the hotel but also to ensure that they know which data must be reviewed and which issues or actions remained outstanding since the last visit.

On the other hand the CRA must take the follow up actions for the previous visit. This includes but is not limited to capture all detected findings, issues and protocol deviations in the related systems, write a detailed report of the reviewed patient data and counted investigational product, address or escalate the issues to the right individuals and summarize all this in a follow up letter to the site.

Depending on the structure in the company the CRA might also be involved in site payments, collection and upload of documents to the electronic document management system / trial master file or other administrative tasks.

There will also be different meetings with project teams, line manager or other departments where the CRAs need to attend.

When the CRAs are onsite they will in most cases start the visit with a brief conversation with the study site team members to answer questions, clarify requests and agree on a time for the meeting with the study coordinator and investigators to discuss any findings they might have. Afterwards the CRAs will review the informed consent of enrolled patients first before they start to check that patients were correctly enrolled into the study, all assessments were done as per protocol and the documentation is accurate and correctly transmitted to the electronic data capture system. There might be different logs that have to be checked as well as the site regulatory binder which is the source for all study related documents and site team members qualifying documentation. The CRA will also conduct drug accountability of the investigational product and review the temperature storage logs to ensure that there were no issues with study drug dispensation and storage or patient compliance. This might be done at the site’s pharmacy and requires a very good time management and planning in advance.

At the end of the visit the CRA discussed findings with the investigators and study nurses or pharmacists, explains the expected corrective action or further escalation processes including the timelines. This requires excellent communication skills and a strong attention to details.

At the conclusion of the visit the CRAs will leave the site and provide further information as part of the visit follow up.

There are a lot of great sources of information and inspiration if you want to learn more about a day in the life of a CRA. One of them that we would like to recommend to you is this video, but you can also find some interesting highlights and further resources here.

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