At IAOCR we’re always excited to speak with people that have a passion for improving approaches and standards. This month we’re delighted to share our interview with Elizabeth Edwards, SVP Oncology Development at Chiltern and member of the IAOCR Executive Advisory Council.
Thanks Elizabeth for telling us about your clinical research career, your views on the biggest challenges for our industry and your thoughts on developing CRAs and project managers for the future . . .
1.How long have you worked in the clinical research industry?
I have worked within the clinical research industry for about 25 yrs.
2.How did you get into clinical research and what career path did you take?
Originally, I decided not to go to medical school, and I ended up taking a job for the Environmental Agency as a tester for clinical research materials. In a conversation with a friend, she asked me if I enjoyed my job, I said I did and she suggested that I might like to become a CRA. I did some research as to the best company to work and train with and I ended up working for Quintiles for 4 years. During this time I could not understand why it took so long to write a protocol so I decided to go and work for GSK, which I did for 12 years. What I really wanted to do was to understand the drug trials process.
After working for GSK I took a year or so out and then started up my own consultancy firm, which was an incredible journey. I worked with lots of small biotech companies and got to be a project manager for new drugs and also choose the companies I worked for. Eventually I got tired of working from home and wanted to be back working as part of a team again. I went to work for Inspire Pharmaceuticals, they created a position for me as Head of Respiratory and then were eventually purchased by Merck. I was then looking for a new challenge outside of pharma and North America so I went to work in Novella Clinical as their Vice President of Operations based in the UK to help try to turn the business around, which we achieved over a 2 year period.
Novella was then bought out by Quintiles around the same time as I was moving back to the US. I stayed on for a further 2½ years and then moved to work for Chiltern.
I am delighted to be at Chiltern now. From the very beginning the culture and people within the business for me were a perfect match!
3.What do you most enjoy about working at Chiltern?
I love the collaborative and calm business culture that Chiltern has. Even when things get tense the team has a great sense of humor, we focus on resolving the challenges but don’t blame each other. Maybe this is largely due to the the company’s European history.
4.What is the most challenging aspect of your role?
The most challenging aspect of my current role is that I know how and where we need to take the business, but the resourcing challenges across the world make this difficult to achieve. It is a very competitive market place out there; Chiltern is being creative in how we attract key talent at the right level with the right skills.
5.What is the most rewarding aspect of your role?
It is fantastic to be part of the team at Chiltern Oncology who are working on the most innovative drugs and devices in the world – to see how it is all developed is awesome.
6.How has the industry changed since you started your career?
The industry has changed a lot since I started. A big influence in this is the regulatory changes. Initially the industry was highly regulated, then it swung back a little and now we are very heavily regulated again, which can be incredibly restrictive.
7.What advice would you give to someone starting their clinical research career?
Start at the bottom. If you are going to be in clinical research, start out as a CRA and do that for a bit. Understand why and what people deal with and you can do anything. I think that it is harder to be a CRA today than it has been in the past.
8.Describe yourself in five words.
Tenacious, humorous, positive, problem solving and hopeful.
9.What do you think the industry should be doing to attract, train, qualify and retain CRAs and project managers?
Lobby the pharmaceutical companies first to help them understand what it means to be a CRA. Understand what it looks like in reality versus on paper. Rare diseases, electronic data collection, etc takes longer than it has done previously and is burning out our people.
If we could give the new clinical researchers coming into the industry a true taste of what clinical research needs to look like that would really help. No program currently really does this. Companies can be reticent to invest in accreditation as across the industry we have a high staff turnover, we need to find a happy medium. CRAs have not had the training I had, often they aren’t competent.
10.How is Chiltern addressing this industry-wide issue?
Chiltern are looking at creative ways to help, retain and support CRAs which includes: less days on the road (8-10 versus 15), providing admin support, growing and developing staff careers and skills, and achieving more of a balance between being away and being in the office.
11.What impressed you about IAOCR and why did you agree to join the Executive Advisory Council?
I first encountered IAOCR when I lived in the UK and was working for Novella Clinical. I was completely impressed. I was unable to persuade my senior leadership team at the time to invest due to lack of resources, we were short on CRAs and it was really short sighted. Chiltern are more long sighted and willing to invest in their people, ensuring they have the right skill set to do their job.
We are just launching a mentoring program at the moment – having two CRAs working together, one experienced and one more junior to help build up experience. We are piloting this program and interviewing people to come on board. I am really interested in ensuring staff have the right skill set for our industry.
12.What do you think will be the top 3 challenges for the industry in the next few years?
The top 3 challenges across the industry in the next few years will be:
- Risk based monitoring becoming a reality
- World politics
Many thanks to Elizabeth for taking the time out to speak with us. If you would like to know more about IAOCR accreditations and workforce quality solutions please email us or telephone +44 1628 784906 (International) 01628 784906 (UK) +1 855 407 6679 (US Toll Free).
By Sophie Comas, Marketing Director – IAOCR