The Clinical Research Profession: Developing a Clinical Research Professional Identity

With Denise Snyder

Christine Senn: 

I am so excited to present my interview with Denise Snyder, who is going to talk to us about her thoughts on clinical research workforce professionalization and the general landscape of clinical research and staffing. I cannot wait for this one.   

Denise, if you could please describe your philosophy regarding supporting clinical research through the workforce, I would love to hear it. 

Denise Snyder: 

Thanks, Christine. The clinical research enterprise is recognized as the evidence generation system, right? There are many calls to action to increase our efficiencies, to deliver more therapies derived from biomedical research. But often an overlooked and critical piece to this delivery is the clinical research workforce. Today, this represents an array of expertise from investigators to sponsors to CROs to sites. But what is often missed is how critical the boots-on-the-ground people are to the success of each of these areas. If we do not have the staff, whether in person or meeting participants at a distance, we will not move any drug development and delivery forward – or at least we are going to experience some delays. Investigators, sponsors, CROs, and sites all have much to gain. But what are we doing to make sure the clinical research professionals who work with the participants to support the investigators, sponsors, CROs, and sites, and our patients, what are we doing to make sure that they are recognized and that they too have skin in the game? I talk to my staff a lot about this need to feel committed and have skin in the game. At Duke, we rely on site prestige, investigator reputation, and an altruistic nature, but that is not enough. We must do more to ensure recognition and commitment to our staff for clinical research. We must identify them. We must thank them. We must ensure that we will back them up. We will provide solid onboarding and training. We are going to prepare them, listen to them, pay them. The list goes on. With all of this comes a commitment from the clinical research professionals to be professional, to recognize their job is important every day to so many people. And from my perspective, doing it well really matters. All of this must translate to an improvement in the quality of what we are doing, in terms of research as care, and every day being a professional really matters. So that is how I see things. 

Christine Senn: 

I love that because you have made the point about saying thank you to people. And we do not say thank you often enough to nurses, to physicians-- but there are so many people who help along this process who are medical heroes. I think that people in clinical research are medical heroes. You oversee a large, very well-regarded academic medical center's (AMC’s) clinical research division. I personally loved working in an AMC for many reasons, and yet I also know there are challenges. In 2013, the Joint Task Force for Clinical Trial Competency developed 8competency domains. Tell me about what opportunities and struggles you saw in implementing those competencies and how you handled them for Duke University. 

Denise Snyder: 

Well, first, it is important to understand that this was a challenging undertaking no matter when you try to do it. At Duke, we tried to do this before I got into this position. I was in a Research Practice Manager position of the School of Nursing portfolio at the time, and we really had a failed attempt at this. And part of the reason for that is we did not have the right engagement from leadership. We really were just trying to do it at a manager level. In 2014, we took several steps to begin to examine our current job challenges in clinical research. Even though I had experienced this before, I really felt like I would partner up with our Human Resources department, plus a lot of leadership above me, and of course all the folks in the trenches. We had over 80 job classifications that researchers used to employ staff across our enterprise. It was such a mess; it was difficult for Human Resources to understand when somebody is requesting a job, how they are comparing that to another job in another unit.  

We are a very large organization, so we used the Joint Task Force framework publication as a starting point. We established 12 jobs for clinical research professional staff roles that were well-articulated, competency-based, appropriately matched to experience and education level, and included descriptions that were more contemporaneous with the shifting clinical research landscape. In 2016 – it took us 2 years to work on this project - we mapped over 700 research staff by pulling in representatives from human resources and clinical research experts across Duke. This was a detailed process outlined in our publications but, in brief, it involved reviewing employee lists identified as key personnel in IRB protocols, employees providing their resumes highlighting their experience, managers reviewing the lists, resumes, and organizational charts. Employees completed a job responsibility survey that was reviewed and confirmed or not by their manager. The results were submitted to HR. The professional workgroup and staff were mapped along with a salary adjustment as applicable, based on a market analysis of those twelve jobs I just mentioned. That is a very different thing from when we had 80 plus jobs that we couldn't even track and understand how they were being used. This has been an organized, productive program at Duke now known as Workforce Engagement and Resilience, or WE ARE.  

Prior to mapping, we had a 3-year attrition rate of about 23% in clinical research. Post-mapping, that rate went down to 16%, about a 30% improvement. While, like many AMCs, we experienced an increase to about 20% attrition during the pandemic, these rates have fallen back to about 17% over the last couple of fiscal years. Overall, we are doing well, and we've tried with WE ARE to foster a community of belonging. WE ARE is not just about the job structure and ladders; it is about creating a community of clinical research professionals at Duke who have support, training, and resources from their leaders and managers who work at Duke. We created onboarding training, professional development, and a research professionals' network with mentoring for new-to-Duke cohorts of clinical research staff and monthly professional topics hosted for our staff to attend. They do not have to, but it is something extra they can do. It is about helping them build up their skills, their knowledge base, and how the organization really works.  

Christine Senn: 

I must imagine that this is part of the turnover, as opposed to the full reason for the lack of turnover; the betterment is that people in the organization understand that these are clinical research professionals. You are not a professional if you have 80 different job descriptions because then everyone is too individual. Clinical research is hard enough to understand. When you have that much discrepancy between each person in the role, I would think that makes it even harder. They probably feel more of a cohesion having fewer job descriptions, but also other people understand what those roles are. Is that what you found? 

Denise Snyder: 

Yes, we see that. We get feedback from our staff. We have created within those twelve roles several roles that are considered tier-advanced roles. They can move within the job, and they can demonstrate competencies in the tier advancement process. When they do that, they get an associated raise with that, but they do not have to leave the job. And that becomes critical to the continuity of the actual clinical research conduct. One of the frustrations of faculty PIs is, "This coordinator's going to leave and work on this study over here after a couple of years." We are really trying to identify a cohort of individuals who can stay in their job for five years or six years or 10 years because of the grant funding and the projects that they might be working on with a particular investigator or several investigators. We are trying to give people an opportunity to stay and not create so much turbulence, even by jumping across lateral positions at the institution. 

Christine Senn: 

I remember when I very first started, I was starting in pediatric oncology, and most of the trials were for the National Cancer Institute. At some point about 2 years in, I wanted to have some growth and they did not have a great way to do that. It came about that I could have a GSK orthopedics trial, which is a completely different thing. I was excited again and felt like there was growth because I was learning something new. Growth can come either by going up the tiers or the opportunity for professional development, which I think is a huge way we engage people. 

Denise Snyder: 

I would say you also need some compensation to go with that. It is not just enough to just keep learning and building without some acknowledgment that you are becoming a better and more skilled and more competent professional. Your worth to the institution, to the job, to the study should be more than somebody who is just new and brand new and walking in the door. 

Christine Senn: 

That is a hundred percent true as well. You mentioned the investigators, and one of the topics that you and I have spoken about in the past is the hospital RVU system. RVUs are standardized systems whereby physicians get credits for different types of visits that can determine their success in the company or hospital and determine their pay. There is something about the RVU system that can dissuade physicians from wanting to engage in research. I feel certain that physicians intend to do the best they can for humanity, but we must be realistic that people do what is easiest and what best serves them, for the most part. What would you do to change the RVU system regarding clinical research? 

Denise Snyder: 

There is a lot that needs to change, and I think it has been a very big challenge for all different kinds of sites, whether you're a large AMC or you're at a site that's trying to accept some research. First, RVU stands for Relative Value Unit. I think those of us who work in academic medicine see it all the time because it is really associated with CMS and CPT codes and things like that. The issue has been differences between compensation systems for clinical and academic work because research falls under academic productivity, and it has been difficult to measure that academic productivity. There are many activities that it encompasses besides research output. It might be sitting on a professional committee; it might be committing time to the department mentoring; and these kinds of things. It is hard to quantify and give credit to that, especially to our clinical faculty who are specific in the clinical realm. Research falls into this category. It is not easy to measure very objectively, and typically a measure that offers some compensation for academic productivity. It can be so variable across the institution because our research and our faculty have appointments in the departments. That itself leads to much interpretation because the department may set their decisions around what academic productivity is. For us at Duke. we recently moved from the private diagnostic clinic, a for-profit company physician practice, to the Duke Health Integrated Practice today, called DHIP. It is the new clinical practice model that's part of our health system. We hope to be more strategically aligned and better equipped to improve access and grow while being able to recruit top providers and staff into our organization. It is a big change for our physicians and administrators, but I hope it's going to give us an opportunity to revisit research RVUs. I have noted that some institutions have tried to implement an academic RVU, but that includes all academic activities, and it is not just focused on research.  

When you think about the constraints that so many health systems face today, for instance, they are digging out of financial challenges post-pandemic. We understand that. We know that we feel it as a school. It is understandable that clinical time becomes the priority: The financial status that the health system is critical and there have been so many changes to billing and healthcare. It continues to be very tricky. The pressures to see more patients drive those challenges for the clinician to integrate research into their practice. As researchers, it is our obligation to find ways to make it easier, by removing the burden on the clinician and providing appropriate compensation. We are going to need to create a policy that values research activities for each of the clinicians to feel like they're productive and that they're given something for their effort that's equivalent to patient care activities. Our views would be specific to research tasks only in the care for those research patients. Ideally, each study would have some type of unique RVU reimbursement plan that is based on whatever the anticipated effort is from that clinician. Crafting this will be challenging, and we will have to manage it through operations. It must be reviewed by IRB for research activities to ensure it is not perceived as an inducement for patient referral to research. I am hopeful that we can revisit this in our new integrated practice model once the dust settles. Right now, things are tough on the back end, and there are still a lot of our physicians who are not fully comfortable with the new DHIP model. There is still much to be worked out.