If you’re interested in the science or medical field but would rather be behind the scenes as opposed to working with patients, you might enjoy a career as a Clinical Research Associate. CRA’s are the professionals responsible for making sure clinical trials are run safely and properly and it can be a lucrative field, depending on the level of work experience.
To help you understand the responsibilities of a CRA as well as the career path you should be on, we spoke with two professionals from Sutro Biopharma, a San Francisco-based clinical stage company which has pioneered a compelling and unique way of discovering, developing and manufacturing therapeutics with a focus on next generation cancer therapeutics and autoimmune disease.
Linda Fitzpatrick is Sutro’s Chief People and Communications Officer whose insights into hiring at a biotech company are invaluable. Jason Kuriakose is Associate Director, Clinical Operations at Sutro and someone Linda refers to as a “clinical trial superstar.” They offer different unique perspectives, so we included them both in this article. Let’s start with Jason.
What are the main responsibilities of a Clinical Research Associate?
Jason: The main responsibilities of your traditional CRA haven’t really changed that much in the last decade or so. They're supervisors for us, they're the main point of contact between a sponsor or CRO, (contract research organization) and the site itself. Some of the day to day outside of providing supervision include regulatory document review, source document verification and drug accountability.
Linda: What I've noted in the 25 plus years in the industry, relative to recruiting for clinical research positions, is they do tend to be more therapeutically focused than they were in the past. For example, we're an oncology therapeutics company and so we give great priority to candidates who have had prior oncology experience. So, I think it used to be a bit more disease agnostic, but I think it very much has become more disease specific.
So, if we had two equal candidates, one with cardiovascular experience and no oncology, and one with oncology and maybe other therapeutic experience, we would probably tilt to the oncology experience.
What kind of formal education/background do you need to be considered for the position? Is there a specific degree people should target?
Linda: We don't require any specific education. I think people tend to have majored in - broadly stated - the sciences. So that could be somebody who has received a degree in pharmacy, it could be somebody who's received a degree in chemical engineering or biological sciences. I think that, for us anyway, a bias to somebody who's got some level of scientific training but there's actually not a specific degree requirement. We also see lots of folks who were pre-med or pre-pharmacy, who pivot into clinical research.
What types of soft skills do candidates need to be considered?
Jason: It would be great for CRA's who can effectively communicate with healthcare professionals, having that exposure to medical terminology is a definite plus, general knowledge of clinical trial design, and maybe some specific therapeutic area knowledge. And then when it comes to travel, strong organizational skills is very important. Because sometimes, in one week, you might be visiting three different institutions. And you might have to fly from one city to the next, in the same day.
Linda: Being able to work with a wide range of personalities. In the clinical sciences field, there's very much a focus towards patients, and very much focused towards healthcare professionals. So being able to understand what's required to develop relationships with both internal audiences, teams that are very interested in updates on clinical trial progress. So you've got to have internal relationship skills and external relationship skills. Organization, detail orientation, accuracy, and conveying pretty complicated concepts are also very important.
Are there any specific personality traits that make someone a good Clinical Research Associate?
Linda: We really do manage towards selection relative to somebody’s ability to collaborate, collaboration is our most important skill set from a sort of deliverable perspective.
Jason: It's a people facing position. You're interacting with a lot of hospitalists; you're interacting with study coordinators as well as folks from your own team so it's good to have a friendly and outgoing personality and a helpful attitude.
Do you need prior experience in the field to be hired in an entry level position and if so, how do candidates gain that first experience that’s needed?
Linda: Yeah, that's the classic dilemma. I think entry level clinical research associate positions are fairly few and far between in our industry, most people do want some level of experience. It doesn't need to be decades, but a year or two. I'm a big believer in internships, doing anything you can to get inside of a clinical research organization, it really does provide, even if it's a summer experience, it gives you a really important leg up.
Or somebody who's been trained as a nurse, for example, and may have interfaced with clinical research associates from organization from companies or clinical contract clinical organizations, that's really important experience. I think it can be experience that is outside of the mainstream of that of a company but has actually prepared you to understand what some of the issues are.
Should potential candidates target pharma companies and medical institutions or look for a position in a smaller company to gain experience?
Linda: There's advantages to working with larger companies in that they do tend to have more bandwidth to hire at the entry level, where smaller companies really need to have every position be impactful and so that prior experience can be really important.
Smaller companies, though, do tend to be a little bit more nimble and so somebody who might interface a lot with our clinical research team, and have an interest in it, probably that career development pathway is going to be a little easier to obtain at Sutro than at Pfizer, for example, because you're going to have the ability to get some first-hand experience and just as important, develop relationships as well.
What is the average salary range for a Clinical Research Associate position?
Linda: The field for clinical research folks is among the most competitive of any area within biotechnology or pharmaceutical companies right now. We're all looking for the same people to help drive our clinical research programs and our success. And so I would say from a compensation perspective, it's one of the areas that has grown most pronouncedly over the last five years in terms of salary competition. It does tend to be a national market and it also does tend to be fairly consistent amongst small and large companies.
I think it's really more driven by years of experience, so I would say at an entry level, somebody who has zero to two years’ experience, the median salary probably tends to be in the $80 to $90,000 range. If you've got three to eight years’ experience, you're going to be in the $125 to $150 thousand dollar range. If you've got eight or 10 plus years of experience, you're going to be in the $175 to $200 thousand dollar range.
What is the career development path for someone who wants to pursue Clinical Research Associate jobs? Do you have any guidance or insight for prospective candidates?
Linda: I really think there’s no substitute for curiosity and experience. So I really encourage starting in college. When you decide you're interested in this field, do all you can to associate yourself with an internship or even volunteer activities within a company's clinical research function. And then, do research to understand the skill set that's required, good attention to detail, great interpersonal skills. financial acumen. Find the company that you want to be associated with and even if you can't get right into the clinical organization, align yourself with a company that's got an appetite for thinking about internal candidates for internal transfer into clinical research. Align yourself to an important area, maybe a project management or basic research, that's going to give you some good background.
Jason: One piece of insight that I've picked up over the years is you don't have to go directly through a company to necessarily work with a company. A lot of the positions in my career have come through recruiters which has been very helpful. And from a personality perspective, being open to different tasks and assignments and being willing to take on different projects is a huge plus, because no two studies are exactly the same. The more differences you see between studies will add up to more experiences that you gain. Having an open mind and not being scared of new opportunities is definitely going to give you an advantage.