How Duke Is Improving Clinical Research Workforce Retention

Can you tell us about dealing with high turnover and the impact?

Fundamentally, if you don’t have a good workforce and high-quality staff to work on studies, then you don’t have high-quality-studies. There is high turnover in the Clinical Research Professional workforce and of course, turnover brings with it the cost of new employees, the cost of the management time and the potential for management burnout. So, the potential for quality, cost, and time impacts is huge. We have done a lot at Duke to address CRP workforce issues and it’s worked really well. Even throughout the COVID pandemic, while other CROs & Academic Medical Centers may speak about 20-30% CRP turnover, we’ve been able to maintain our attrition level at about 18-19% attrition.

While you can’t directly link the stability of our CRP workforce to a single specific initiative, I think it has a lot to do with the work we’ve done to create a professional identity at Duke by having clear paths for clinical research professionals to come into jobs and to stay in those jobs while they advance their careers. CRPs don’t have to come in and constantly job-hop, starting over and over. We’ve created pathways where you can come in, stay with your group and still advance, which I think makes a big difference.

What is Duke doing differently that leads to having that lower attrition rate?

There are a lot of factors, and every institution is different. But what you’ll see is the variability in jobs and job descriptions itself is part of the challenge. At Duke, for example, I can start in a job as a Clinical Research Specialist coming in right out of school with a structured onboarding program that includes cohort mentorship, as well as structured online training modules developed by people that have degrees in adult education. Once I’m through that orientation period and I’ve been working on my job for a while, I can apply for a Clinical Research Coordinator (CRC) or Regulatory Coordinator (RC) position. Once I’m in a CRC or RC position, I can be in that same position for the next five or more years, and still get a promotion and a salary increase every few years, by promoting myself through a tier advancement process based on competency development.

So as a person just starting my path, I can see career progression opportunities, extending through to high- level project management and clinical research oversight jobs. Meanwhile, in a lot of other places, there’s no specific structured jobs so there is no clear career path for those in “Coordinator” roles. You may have five “Coordinators” who all have different job titles. That also leads to equity issues where I may have the same job responsibilities as somebody else but make half as much because of a difference in title. A person coming into the Duke structure knows their career opportunities, to some degree. You can see and control your future professional life at Duke a little easier than you can envision at many other places.

"We’ve created pathways where you can come in, stay with your group and still advance, which I think makes a big difference."

Are there more foundational issues for clinical research professionals?

The root cause of the crisis, in my opinion, is the lack of professional identity for a huge group of people who are fundamental to moving a product from discovery to health translation. If you think about an academic environment and all the interprofessional work that goes on in healthcare teams, successful collaboration happens because the MDs, nurses, etc recognize each other as professionals. Meanwhile, clinical research professionals are largely viewed as plug-n-play: they just need a coordinator. This is fundamentally built into the system from the way sponsors structure their funding to the way resources are allocated for on-the-job training. The idea that you have thousands of people contributing to something so important but that it is not even recognized as a profession by the Bureau of Labor Statistics is fundamentally off-putting. Moreover, advocacy for CRP professional recognition and inclusion is regularly dismissed by those who have the power to push for systemic changes.

Is there anything that can be done about this?

I think there are a lot of different things that could be done. We need a more diverse workforce. We need a more stable workforce. We need structured jobs. The first practical step is standardizing job descriptions. There is a lot of work going on in that space across academic institutions and CROs to come up with a standard language of what is included in these jobs. While we’ve done this at Duke you can’t do this in isolation and have the needed effect. That’s got to happen before much else can, because if you don’t know who’s working in the space, you can’t improve training, you can’t improve pipelines, and you can’t effectively advocate. 

To improve diversity and representation, we need to have more inroads from diverse populations instead of having systems that reinforce recruiting and recycling talent from one another. We can’t make any improvements on diversity and inclusion of our workforce if we’re just rehiring the same CRPs over and over from one institution to another. We need to partner with some of these wonderful clinical research training programs from local community colleges and other colleges with diverse student profiles to provide matriculated students a place to go in the clinical research workforce. We then need to take from the fellowship model used for PIs. They get funding and grant mechanisms geared towards retention. I would love to see a mechanism where I could take a student out of one of these training programs from a local community college, stick them in a fellowship at Duke so they can get hands-on experience, and then when that fellowship ends, they get hired into a coordinator position. Those models are going to give us much better workforces and opportunities for cohort building and cohesion among the workforce at each site. Those models make people feel validated and satisfied and more likely to stay on their job.

"The root cause of the crisis is the lack of professional identity for a huge group of people who are fundamental to moving a product from discovery to health translation."

How do we approach the issue of increasing the number of clinical research staff within institutions?

One of the things that’s had a lot of discussion lately are minimum qualifications. The argument we hear is that in many institutions, there is a requirement for two years of experience for an entry-level position. While clinical research is complicated work that requires specific training, if we set our entry level at two years’ experience, how will people ever get experience?

In my mind, the solution is to look at the bulk of the work that needs to be done. Instead of trying to change the minimum qualifications needed for coordinator level jobs, let’s carve away those more fundamental tasks and skills into entry jobs rightly scoped in responsibility for those with training but without two years of experience. With such jobs available, people from a wider variety of educational and experiential backgrounds will more easily be able to enter the workforce.

If we succeed there, the next challenge is to change the resourcing structure coming from sponsors. Generally, study budgets start with the minimum amount of effort for a CRP who absolutely knows how to hit the ground running. Even more so, federal grant bottom lines have remained stagnant for decades. Given a research infrastructure dependent on these funds to support the workforce, this means there is really no opportunity for truly entry-level individuals. We need funding mechanisms that recognize mentorship, growth and management as fundamental to study conduct. Instead of saying that X project requires a minimum of one FTE, we need support for something more like 1.2 FTEs because it requires one person to do the job as well as the management and oversight of that person, so that we can build career growth into the system.

Right now, Duke’s entry-level Clinical Research Specialist jobs require an Associates Degree and no experience. However, these jobs are rarely posted because the PIs are financially constrained to need experienced CRPs who can hit the ground running. We need to change that dynamic in addition to assessing the minimum qualifications required across the national workforce.

What is the responsibility of sponsors, in contrast to sites, when it comes to addressing these workforce issues?

It’s got to be a partnership. From the site perspective, there is only so far you can go. You can make the infrastructure changes, solidify the jobs and create the career paths but all of that work costs money. It’s unreasonable for us to suggest that every site out there needs to restructure the workforce without any resources. If we were talking about a health system infrastructure problem, we would use our streams of revenue to fund the change. If we’re talking about clinical research, we need to be able to do the same. We have been able to do our work at Duke because of our CTSA and support from the School of Medicine, and because we have strong advocates and strong partnerships with our HR and business-level colleagues. But to make it sustainable, workforce development and maintenance needs to be supported by the money allocated to run research. So, if a sponsor wants to require increased diversity in research participation, we need increased support financially to do all the important work to make that happen.

What can other institutions like community hospitals do to overcome the workforce issue?

The CRP advocacy community is very collaborative. Even in those structures, if they are doing research or partnering with other institutions to do research, there are operational administrative folks overseeing the research at that site. If they could allocate a small part of those individuals’ time and efforts towards implementing some of the things that we’ve done, and that our colleagues throughout the CRP community have done – which we share publicly – they could take our models and modify them for their institutions. Job descriptions and career pathways are very approachable now that models are widely available.

For more information on CRAACO: Clinical Research as a Care Option, visit CRAACOevent.com.