With over 35 years’ experience in the clinical research industry, Karen Ruthven, IAOCR’s Global Head of Workforce Competence Services provides an interesting perspective on the clinical research industry and what her work tells us about the current environment. Describing herself as energetic, organized, responsible, thoughtful and empathetic; learn more about a key member of the IAOCR leadership team here:
How did you get into the clinical research industry and what career path did you take?
I began my working career at The Wellcome Foundation as an in-house CRA, helping to run Phase 1 studies. I then worked for a number of small to medium sized pharma companies starting as CRA and working up to Project Manager before joining Innovex, then a UK based CRO, in a line management role. I have always enjoyed coaching and developing people and after a number of years in senior management positions in CRO and SMO companies, managing large teams of people, I moved into training, setting up the European Clinical Operations training department at PPD. After a brief spelI at Amgen in Senior Training roles I decided to set up my own training consultancy which I continued until joining IAOCR in 2014 as Director of Education and Training.
What do you most enjoy about working at IAOCR?
Working in a small dedicated team of people who have the same purpose and vision but are from a range of backgrounds and approach the work in a totally different way. It makes for some lively meetings (!) but I feel that despite all my years in the industry, I am learning more each day through these interactions and the range of projects that we are involved in.
What is the most challenging aspect of your role?
Every project we do is bespoke which means each time we start a project it is usually slightly different in some aspect than any others we have done before, which creates an exciting challenge. No two days are ever the same and it keeps you on your toes having to come up with new solutions every day.
What is the most rewarding aspect of your role?
Seeing that we are really making a difference to our clients in terms of quality of work, retention and motivation of staff who have been through the accreditation programs.
What advice would you give to someone starting out in their clinical research career?
Make use of all the resources your company provides, shadow more experienced people where possible, take all the opportunities offered to you and keep an open mind about what you think you want to do. And always remember that the patients’ safety is the most important responsibility you have.
What is the biggest challenge for the clinical research workforce?
I believe the biggest challenge for the clinical research workforce is similar to the challenge for all workforces at present; the lack of certainty about the future. We all know the saying that the only certainty is change but the rate of change in the current digital age is now exponential.
When I started in the industry, my career pathway and choices were reasonably clear. Now we do not have a clear idea of how some of the innovations in both technology and science will affect the way drugs are tested in the future. The media is full of stories about how AI is going to revolutionize medicine by performing tasks such as diagnosing disease and changing the methods we use for assaying new drugs – but how will that actually affect the people who are currently involved in clinical research? The challenge is going to be how quickly we can adapt our processes and the way people work to the emerging technology. A new graduate joining the workforce is going to have to be ready to adapt and re-train for different roles, possibly several times over during their career.
What do you think the industry should be doing to attract, train, qualify and retain talent?
The industry needs to be much more proactive in advertising the careers available in Clinical Research. I am a mentor to Biological Science students at two universities in the UK and until I started speaking to the careers advisers and faculty members, very few students were aware of clinical research as a career. Training should be lifelong, now more than ever – companies need to invest in providing ongoing effective training to all staff, not just online read and sign type exercises. Using some of the new technologies available, there are so many great ways to train without breaking the bank or taking people away from their jobs for huge amounts of time. The industry is all about quality and safety; this cannot be maintained without giving people time for training.
Obviously in my role I am passionate about ensuring all clinical research staff are qualified to do their job and many companies are now accrediting their staff through our programs. We work in a highly regulated environment and there should be an emphasis on an independent assessment of competence – just having performed a role for 10 years does not mean that you are competent.
To retain staff first and foremost, you need good line managers. Providing varied opportunities for growth may well replace the traditional career path as organizations have to change and adapt to the new technologies. And finally, the new generation of graduates may have different work expectations which organizations will need to be aware of in order to retain their talent.
Do you think the industry is taking on board the competence philosophy and mentality?
Slowly! I think the idea of competence is still misunderstood by a lot of people. Throughout my career staff have always been judged on years of experience rather than whether they can actually do the job well; the competence message is only slowly being taken up. Those organizations who do take on the philosophy and translate it into training and accreditation programs are finding that it is hugely motivating for their staff. The staff say they feel valued and supported and the companies are finding better retention rates as a consequence of a clear career progression based on competence rather than time in post.
How do you think IAOCR is helping to address the talent crisis?
The lack of CRAs has been severely affecting the industry for some time now; IAOCR is helping to address this by championing the idea that it is not necessary to have staff with two years’ experience, they can be fully competent with fewer years’ experience and have the accreditation certificate to prove it. The industry is a very conservative one and is nervous of this idea but I think as more CROs begin to be able to place accredited CRAs on projects earlier (and we have evidence to show this is the case) we will start to see a decrease in the talent crisis. In addition, we are involved in a number of initiatives such as the Clinical Scientist Apprenticeship, to bring universities and industry together to look at innovative solutions.
What do you think the top three challenges are for our industry in the next few years as you would see it?
Decreasing margins, retaining staff and keeping up with technology.