DECEMBER - JANUARYLIFE SCIENCES REVIEW8IN MY OPINIONTHE SIGNIFICANT INCREASE IN DEMAND FOR CLINICAL RESEARCH ASSOCIATES (CRAS)By Helen Yeardley, Senior Vice President, Global Clinical Operations, ICONuch has changed since I started out as a CRA over 25 years ago ­ starting with the complexity of protocols for clinical trials, adding in new methodologies for monitoring data and patient safety, and culminating in the increased digitisation of clinical trials, to name just a few examples.There are also a number of things that haven't changed much ­ the fulfilling and rewarding career that the CRA role can offer, and of course, the fundamental and hugely important role that the CRA plays in the clinical trial process. Given this, it is incumbent upon all of us in the industry to look at how we can address the challenge of increased demand for CRAs that has become particularly pronounced over the last number of years. And whilst the role of the monitor is evolving, and technology is advancing, the pace of change in our industry is moderate, so that in the current environment, there remains a need for travelling CRAs who review source data.The demand for CRAs significantly outpaced supply over the past two decades, though this shortage has become more pronounced in the past 3 years. For example, in 2018, the industry had a global shortage of over 17,000 CRAs due to the rising demand for well-trained, experienced CRAs. There are a number of reasons for this. Firstly, as more complicated scientific assets and/or targeted therapies are developed, the clinical trial data volume rose in scale and complexity. In addition, we have also seen a significant increase in the number of sites and patients, which is in part due to the increase in trial patient sizes since the early 1990s.At ICON, we are looking at how to address this current challenge from number of practical perspectives. Firstly, we've invested considerable effort in learning and development supports for people looking to start a career in clinical trials. The focus here is on attracting candidates who can quickly evolve to a CRA role from a variety of backgrounds and disciplines and ensuring they receive training and support tailored to their circumstances, and to the stage of their career. Secondly, we're looking at innovative and practical ways of how ­ and where ­ CRAs can perform their critical roles.I'll explore both areas in this article.The right support, right from the get-go.The path to a career as a CRA can be varied. Already experienced clinical or healthcare professionals, e.g., study co-ordinators, can look to move into a CRA role. In addition, recent college graduates, particularly those with life science degrees, can embark on a varied and fulfilling long-term career in clinical research using the CRA level as an entry level role. I have the experience to know!When selecting CRAs, we don't look for any one particular background or qualification. Instead, we look at a combination of criteria including research knowledge, experience and a variety of soft skills including communication, motivation, influencing and collaboration. Once recruited, the key to ensuring high levels of competency and ultimate career progression is that, regardless of background, CRAs receive the right support at this pivotal early stage of their careers, building the foundational skills and competencies necessary for a CRA in line with industry standards.At ICON, we don't adopt a one-size-fits-all approach. In fact, we run a number of dedicated CRA training programmes that are specifically tailored to the each CRA in question, and their respective backgrounds. Each of these offer a comprehensive curriculum, including, as one MHelen Yeardley
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