ICON [NASDAQ: ICLR]
The Significant Increase in Demand for Clinical Research Associates (CRAs)
Helen Yeardley
Much 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 would expect, online and best-in-class instructor-led training workshops to lay the foundational knowledge of clinical research. But more importantly, these also include hands-on experience in the form of accompanied site visits, mock visits, simulation visits, and individually tailored coaching, mentoring and skills development.
In this way, CRAs not only develop technical expertise, but also the soft skills that are needed to become a fully rounded CRA, and to build relationships with sites. The ‘mock’ part of our training allows for an objective assessment of progress, along with targeted identification of development needs.The coaching and mentoring part of our curriculum, whilst subjective, is particularly important to foster skills that build strong relationships across all levels of staff at sites.
Coaching is carried out by a knowledgeable team of clinical operations managers and mentoring is carried out by experienced CRAs. Monthly development forums are also part of our training programs, providing the opportunity for up skilling and continuing education for junior CRAs.
We’re seeing the fruits of the investment in these tailored training programmes. We monitor performance quality closely through a variety of mechanisms, and consistently see high satisfaction levels in the performance of ‘graduates’ of programmes.
Importantly, one of the further benefits of these training programmes is that they are moving the dial on the level of experience that CRAs are getting – given the focus on providing hands-on, real-world experience as part of this structured training. In this way, we are shifting the perception that length of tenure in a CRA role should be used as a benchmark for competence. We’re seeing competency levels accelerate, which ultimately is building the supply of experienced CRAs.
Innovative and practical ways for CRAs to perform their role
In tandem with how we both recruit and train CRAs in the early stages of their career, we also see an opportunity to think beyond the current status quo and identify how CRAs can perform their roles in light of the changing clinical trial landscape.
Technology and digitisation have a significant impact on how clinical trials are carried out. Using technology applications allows for the collection of digitised data from patients in a faster and effective manner; but it also may give CRAs remote access to data.
Targeted recruiting and hiring, as well as deployment of hub CRAs, are just two of many opportunities to counteract the current paucity of experienced CRAs
A tangible example of this with regards to the role of the CRA is ICON’s remote CRA hub. A key objective of the hub is to provide sponsors with access to highly experienced and specialised CRAs in a cost-efficient way. ICON has several off-shored hubs in lower-cost locations, chosen based on availability of clinical-research experienced CRAs, along with availability of infrastructure to support a remote team. Hub CRAs collaborate and work closely with in-country travelling CRAs, and their role stretches from data reviewer to site manager.
There are a number of benefits to this. Firstly, sponsors get greater access to experienced CRAs with the required knowledge in complex indications, often in more cost-efficient geographical locations. The seniority of the assigned hub CRAs accounts for the high level of experience and understanding of the monitoring requirements of complex studies.
Secondly, the hub set-up allows for monitoring to occur at many of the sites for extended periods instead of only during a standard working day in the country where the trial is physically being carried out. This is attributable to the various regional locations of the hubs, which can be either in the same time zone as the site, or beyond.
Thirdly, due to the remote nature of their role, hub CRAs do not travel, and as such, overall job satisfaction in non-travelling hub CRAs is higher, resulting in better retention, which in turn increases customer satisfaction.
All in all, as a result, customers and sites get access to the expertise they need, for extended times, and in an effective and cost-efficient way.
Targeted recruiting and hiring, as well as deployment of hub CRAs, are just two of many opportunities to counteract the current paucity of experienced CRAs. We see huge opportunity to apply new thinking and to capitalise on the trends we are seeing across the clinical research industry and apply them to a number of areas, includingsite performance management, risk management, remote monitoring and remote data collection.
I think we can drive real progress in these areas, which is hugely exciting - another reason why embarking on a career as a CRA now will be hugely varied and fulfilling.
