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Through the Ranks

‘The world of clinical research’ is a phrase I frequently use to define what I have experienced to be an amazing, frustrating, dynamic, fast-paced and rewarding industry within which to forge a career. But how does the average graduate navigate the hierarchical path within a sector that is often perceived to be a closed book? Are the stepping stones sufficiently accessible to facilitate progression through the ranks?

Clinical research is often described as one of the most difficult career paths to undertake, and is a world repeatedly subjected to harsh criticism and negative press – so what attracts people to this profession? Getting a foot through the door in clinical research is notoriously hard, so how can one take those initial steps towards a career? I would consider myself to be one of the lucky ones; as a graduate I was fortunate to have the opportunity to kick-start my career in the sector, but it has not been an easy journey.

In any career, support, guidance and, more importantly, training are key elements in aiding development and progression. When the economy took a nosedive, many companies that previously would have invested in training programmes to bring on new recruits and assist in developing fresh talent closed their doors. Those same companies are now only employing experienced people. In the past, I would have considered these to be people like myself, who have undergone extensive training programmes and worked their way up through the industry.

But as many of these training programmes are being shut down, who will be the ‘experienced people’ in a few years? In reality, were these training programmes ever the key to creating experienced staff? And did they help people to develop and grow the confidence needed to progress in the clinical research field?

From the Beginning

As a graduate, I knew little about clinical research or the roles within the field. I was lucky enough to be given the chance by a CRO that, at the time, believed in investing time and money in attracting new talent into the industry and equipping them with sufficient training, information and support to develop within a hugely complex and fast-paced industry. I was taken on fresh out of university as a clinical trial assistant (CTA), and spent the first two weeks in a classroom undertaking a comprehensive induction course on the clinical research industry, with a view to being fast-tracked after six months to become a clinical research associate (CRA). The induction course was designed to provide an overview of all aspects of clinical development, as well as a broad view on the guidelines, ethics and regulations of trials, and why these are in place.

The course gave me a good grounding in the basics: an insight into drug and clinical development; how the industry has become so highly regulated; what is at stake without such thorough regulations; and, principally, what is involved in the safe conduct of a trial.

Greater Awareness

All of these are of paramount importance to someone joining the industry, but what this course gave me more than anything else was awareness. Awareness of the industry as a whole, which differed immensely to the media image often portrayed. It gave me knowledge of what is involved in getting a drug from preclinical to market, the success rate, and the cost associated with it. Essentially, it made me conscious of where I, as a CTA, fitted into this huge machine of an industry. It taught me how important my role was to the success of a clinical trial, and how critical the success of a clinical trial was to any company. But, much more vitally, I came to understand how an efficacious trial could have a major impact on the life of a patient.

With the closure of many of these training courses, the role of the CTA seems to have been maligned over time. The misconception now is that the CTA role is just an ‘admin’ function which can be done with little or no training, as opposed to its true role as the keeper of the trial master file (TMF). The TMF is extremely important to the validity of a clinical trial, but is hugely underplayed by many companies, despite being the first port of call for any inspector.

Lack of Support

As these types of training courses are now few and far between, how are we attracting new talent into the industry? How does the life sciences undergraduate of tomorrow get their foot on the ladder of clinical research, and gain the training and support that they need to kick-start their career? The answer currently is: they don’t.

In the words of Yvette Cleland, Chief Executive Officer at Clinical Professionals: “In the past, the pharma industry had highly developed training programmes for these soughtafter candidates. As the use of outsourcing models and CROs has increased and fewer pharma businesses embark on their own R&D, a substantial gap is developing in newly-trained life sciences graduates entering the market to commence a career within R&D.

“As further financial cuts are made within R&D spend, this already dire situation continues to escalate. The lack of skilled staff entering industry impacts costs, leading to rapid salary inflation, on-boarding fees and retention bonuses. No ‘new blood’ coming into entry-level roles further drives turnover of staff, attracted to higher salaries and bonuses, while CROs and pharma are all fishing in the same diminishing candidate pool. More worryingly, this can potentially impact the integrity of the clinical trial data through the high turnover of essential staff leaving for other, more financially attractive roles.

“Paradoxically, the cost savings associated with outsourcing are rising, due to the providers having less and less skilled workers to place in roles; a non-provision of training and development of highly-skilled life sciences graduates entering industry; and a lack of robust, ‘enhanced’ skill training for current skilled workers.”

This highlights the gravity of the current situation, where entry-level training is virtually non-existent – therefore answering the question of how a graduate navigates the hierarchical path of clinical research: with difficulty.

So, it is questionable whether the entry-level training courses really are the key to experienced staff and progression through the ranks, if companies can easily drop them in an economic downturn.

Path of Progression

Following my entrance into clinical research, I was fortunate enough to have been supported in my role as a CTA and progressed quickly to become a CRA. Being a CRA was a world away from my previous role and, due to my ability to speak French, I found myself monitoring in both France and Belgium.

It has been an assumption over the years that the natural course of progression within clinical operations is from CTA to CRA. This is not unreasonable, and this career step is one that has proved to be successful for many. Recently, companies have tended to shy away from this staff development strategy for a number of reasons – namely, because the roles of CTA and CRA require a different skill set. While this is true and the route is not necessarily appropriate for everyone, just because different skill sets are required does not mean that, with the correct training and support, the required skill set cannot be developed, and then applied to different roles.

However, the cynic in me believes that the reticence to continue this model of development comes back to companies trying to decrease the great level of turnover in roles within their highly experienced pool of staff.

This argument aside, when I revisit my transition from CTA to CRA, and the relative ease with which I managed to achieve this, it comes back to the initial grounding during the training I received at the start of my career, which introduced me to the concept and day-to-day elements of the CRA role. Discussions and role plays had already taken place during my induction course, covering the challenges that face a CRA on a daily basis and different ways of tackling situations as they arise. This training, in turn, facilitated my ability as a CTA to understand the pressures on the CRA, and enabled me to tailor the assistance and support I gave them, thus fostering a greater team environment.

Training is Key

Revisiting the question of “are these entry-level graduate training courses the key to experienced staff?” I would, wholeheartedly, say “yes”. While giving every new candidate the information and support necessary to conduct their job, they also provide graduates with the wider picture of where they fit into the industry, the importance of their role, and what purpose their position has in the success of the clinical trial. These are the key elements that so many staff are missing currently – if they have not been given the bigger picture, how can they be asked to think outside of the box?

With a comprehensive knowledge of the role they are conducting and a deeper understanding of the role above – in this case, the CRA (be it in-house or in the field) – each new candidate is provided with the motivation to develop their career path. Progression through the ranks for me and my colleagues who undertook that graduate training course was made significantly easier because we were equipped at an early stage in our careers with the fundamental basics and background as to the whys and wherefores of clinical research.

Future Change?

Fortunately, some companies have begun to recognise that the lack of entry-level training is an unmet need within the industry, and have started to formulate a more rigorous training programme to support the progression of new candidates. This is of huge benefit not only to those businesses, but to the industry as a whole, as well as to the candidates themselves. New recruits are essential to the industry, and the continuation of the talent pool can only be considered an asset.

I consider myself very lucky to have been able to access the world of clinical research, and to be in a position to have forged a career through robust training and support. This is the path that I would welcome for many entry-level candidates who may be following the same footsteps in years to come. Currently, the industry is at a standstill – however, going forward, perhaps the entry-level route and the ability to progress through the ranks will become more prevalent once again.

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Nikki Harrison has over 14 years of experience working within the clinical trial arena, having worked extensively within CRO, biotechnology and pharma companies across Phase 1-4 trials. She was Associate Director at Takeda Development Centre, responsible for managing many global clinical trials – notably, a multimillion Phase 3 programme which, due to its success, saw the approval of a new drug application in the US for the treatment of type 2 diabetes. Following her role at Takeda, Nikki joined Clinical Professionals as Director of the PAYE contractor/functional service provider side of the business, combining her clinical expertise with her line management skills.
Nikki Harrison
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