A CRA – Clinical Research Associate plays a vital role in a clinical trial. He/she is the bridge between the Sponsor/CRO and the Investigator/Site Team. Regardless of the type of trial, the CRA’s role remains the same. The CRA should take utmost responsibility in ensuring the clinical trial is being conducted as per the approved Protocol, ICH-GCP (R2) guidelines and the local regulations as applicable. CRAs are also called Monitors – a synonym that often is misleading in terms of the primary responsibility.   The ‘monitoring’ visits are often seen as visits where the study is ‘monitored’ or ‘audited’ or ‘inspected’ by the CRO company. These terms often cause mayhem in the minds of the Investigator and his/her site support team. The CRAs, most of them, too often think of their job as ‘policing’ to find out errors. They feel good if they have ‘observed’ more errors from the sites so that they can prepare a lengthy monitoring report. This mindset has to change. The CRAs role is primarily to help out the site in conducting the study as it should be conducted. Rather than ‘monitoring’, there should be training and awareness given to the site team so that the errors (minor or major) will not be repeated by the Investigator and his/her site support team. The site monitoring visits should be a learning experience for both the CRA and the Investigator (and other delegated study members). It is a combined effort keeping in mind the ultimate goal to complete the study successfully and to bring out the product into the market at the earliest which in turn will help the prospective patients and ultimately lead to the betterment of the healthcare industry.   Here are 5 important skills that will help a CRA to become better with each site visit.  

1. Knowledgeable

Knowledge is golden. In the current scenario, there is a lot of information around – but how this information means nothing if it cannot be converted into knowledge. The CRA should have extensive knowledge and be updated on the current guidelines, regulations and other study requirements. The investigator and his/her site team is solely dependent on the CRA when it comes to the trial management and documentation procedures. They do know the study protocol and of course the investigators ought to have the clinical expertise to conduct the study yet they may need constant training when it comes to the stringent documentation practices followed in a clinical trial. Hence the CRA should always be updated on GCP, the study Protocol and the local regulations as applicable.  

2. Approachable

The CRA should and must be approachable. Most of the errors continue to happen in most studies simply because the CRA is not ‘approachable’ to the Investigator in general and the CRC (Clinical Research Coordinator) In particular. It is to be noted that just as the CRA forms the bridge between the CRO and the Investigator, the CRC forms the bridge between the Investigator and the patient. Hence the CRC-CRA relationship should be very cordial and mutually supportive. This alone can help to resolve many documentation issues. The CRA should make himself/herself approachable – especially to the CRCs. Now, an experienced CRC generally knows things around a clinical trial however the problem occurs when it is a newbie. This is where the CRA should assume the role of a mentor rather than a monitor.  

3. Disciplined

Personal discipline is always appreciated and in the clinical research industry the CRA who has self-discipline will go a long way in becoming better at performing his/her duties towards the study. The reason for this is the basic rule in clinical research: if it is not documented, then it did not happen. This documentation can happen only if there is a certain level of discipline. The CRA should firstly be himself/herself disciplined – only then this can be passed on to the site. The CRA should understand that just as he/she is carefully checking the site, the site personnel (especially the investigator and the CRC) are also observing the CRA on how he/she is going about the monitoring business. As the old adage goes: Discipline is better caught than taught. Once the CRC sees the discipline exhibited by the CRA, then that is easily imbibed by the CRC. This only helps in better documentation which ultimately leads to data-integrity and a better outcome of the clinical trial.   To sum up, a CRA who has knowledge will be approachable and the CRA who is approachable and has knowledge should inculcate a certain level of discipline. So all these 3 skills go hand-in-hand in helping the CRA become better at managing the study processes.