Back in the days when all data in the clinical trials was on paper only, pharmaceutical companies had representatives called Clinical Research Associates (CRAs) who were responsible for visiting the hospitals and checking if the information entered in the paper case report form is the same as the medical records. Then the CRA will collect paper copies of the case report form and send them via courier to data management team who will further review the information. Unfortunately, even today many people in human resources think that this is the job of the Clinical Research Associate – to simply check if all the data is entered.

The reality is that clinical trials have evolved. They have become a lot more complex and specialised. There are clinical trials with cell therapy, gene therapy, rare indications, medical devices, etc. These clinical trials require significant expertise from the person responsible for monitoring. The traditional role of the CRA has evolved immensely.

What is required from the Clinical Research Associates today?

  1. CRA should be able to understand complex protocols. These protocols sometimes involve a lot of medical knowledge but with the growing amount of medical devices studies – technical knowledge as well.
  2. CRA should be able to explain the clinical trial to the clinical team in the hospital and be able to guide them to make sure they follow the protocol.
  3. CRA should be able to identify safety signals during the monitoring visits and if they are any safety concerns about patients participating in clinical trials to escalate this and seek further advice from the medical monitor. In order to do this the CRA has to be very familiar with the safety profile of the study drug or medical device.
  4. CRA needs to have knowledge on medications and their metabolism because in many clinical trials there are prohibited drugs to be used along with the study drug. 
  5. CRA often performs remote data review and is involved in study data management. They need to be able to work with big data bases and identify trends.
  6. CRA should know what regulatory documents are available for the study and make sure the hospital has all of them. They need to identify if anything has to be submitted to competent authorities – for example, hospital amended informed consent form.  
  7. CRA should have all required soft skills to work with people, build a relationship with them and support hospitals to conduct clinical trials according to the protocol and GCP practice. 
  8. CRA should be able to identify logistic issues and work with hospitals to find solution for them. For example, issues with courier when shipping lab samples, etc.

And yet for many big pharmaceutical companies and clinical research organisations the metrics for CRA role is how much they have travelled per week and if they have not travelled as per the expected metrics, they are not doing what they are supposed to. I remember often challenging this by saying that we are not taxi drivers. By no mean my intention was to underestimate the hard work of the taxi drivers but more to point the difference – when the taxi driver delivers you at the final address safely their job is done, while for the CRA – when they arrive at the hospital, this is when their actual job starts. 

The misunderstanding of the role of the Clinical Research Associates led to significant shortages of experienced CRAs. Many people felt unappreciated and decided to look for other opportunities. 

Why experienced and knowledgeable CRAs are great asset to the companies?

  1. CRA can make or break your study – Literally! CRAs are responsible for the data to be adequately documented and entered in the case report forms. If this is not done correctly your data will need a lot of data cleaning and even may need to be reviewed again by experienced professional. Therefore, companies need to find experienced and knowledgeable CRA.
  2. CRA knows before your biostatistician if your drug is working or not. They monitor the patients and have information of their response rate.
  3. CRA knows if your hospitals will recruit or not because they have personal experience with a lot of hospitals and knowledge from their network of CRAs on different hospitals and investigators.
  4. CRA can recommend you vendors and will know of existing issues at the hospitals. For example, couriers not collecting lab samples, etc. 
  5. CRA can jeopardise your relationship with the hospital to the extent that they may not want to work with the company anymore. Soft skills should not be underestimated. 

Not everyone can be a good CRA and experience by itself does not constitute good CRA. But having such experienced and good CRA in your team could be a great asset to your company. It is time to start appreciating the work of the Clinical Research Associates.

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Published on 1 Feb 2023