Navigating Challenges in Clinical Research Staffing

Michele Cameron, Director of Clinical Research at Clearwater Cardiovascular Consultants, and Lindsey Morales, Associate Director of Clinical Site Partnerships at Gilead Sciences, share insights from a recent SCRS survey on clinical research site workforce challenges.

Learn about the significant turnover rates for patient-facing staff and obstacles in recruiting and training new coordinators. Lindsey and Michele share actionable steps for the industry to better support site partners, including addressing site fatigue, communication transparency, and collaboration.

Download the Workforce Task Force Toolkit available to SCRS members.

Transcript

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Jimmy Bechtel 0:00

Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks allows our partners and those that we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, And to learn more about our growing community. Today, we have Michele Cameron, the director of clinical research with Clearwater Cardiovascular Consultants and Lindsay Morales, the associate director of clinical site partnerships with Gilead Sciences here to share a little bit more about recent learnings that we have brought to the site community from a survey that the SCRS membership Committee conducted related to challenges in workforce. Michele, Lindsey, it's great to have you with us. Really excited to have another conversation about the ever evolving changes with clinical research site workforce. Michele, if you wouldn't mind, start us off with a little bit of an introduction about yourself and maybe your organization, and then, Lindsey, we'll get one from you as

Michele Cameron 1:02

well. Thanks, Jimmy. Thanks for for asking me to be a part of this conversation. So Clearwater Cardiovascular Consultants is a practice embedded site. We have 21 cardiologists slash investigators and we do Approximately 30 drug slash device studies at any given time. And of course, those are summer and rolling summer and follow up and so forth. We do this in two hospitals and three clinics. We have a staff, a full time staff of eight coordinators support staff, three research assistants and then administrative staff including a regulatory coordinator and an operations coordinator. So I wanted to give you our makeup because it, you know, every site is structured a little bit differently. And we have been conducting clinical research for over 35 years. And I have been the director here for 18 years. So this is a topic that's near and dear to my heart.

Lindsey Morales 2:06

All right, thanks, Michele. Thanks, Jimmy. Yeah, this is Lindsay. I'm, I'm excited to be here. I've been in the industry for about 19 years, almost 19 years. And I've done a host of different positions throughout the, throughout the industry. I've been at a site. I've been at a CRO, I've been at sponsors. But, where I am now at Gilead is really a great opportunity to work with a group of people that are really passionate about what we do. And it made me even more passionate about what I do. And so I'm so excited to get to talk to you today about about about this topic and how we are trying to do our part to make sure that our sites are sustainable and that you know, we make sure that we're doing the best that we can for not only for our sites, but for our patients as well.

Jimmy Bechtel 2:50

Wonderful. Well, again, thank you both for being here and lending your expertise to this conversation. As I had mentioned in the introduction, the SCRS membership committee and its member advisory board helped conduct a survey to learn a little bit more about the workforce challenges that sites are facing and helping us determine how we can help sites better in this space. One of the things we learned from this survey is that sites are experiencing a significant increase in turnover rates of that patient facing staff. So Michele, I'll start with you from the site perspective. Maybe you can share what you observe as some of the contributing factors behind this trend and how those factors then affect the overall research industry.

Michele Cameron 3:30

Yeah, so I'll speak from my own experience. So in 2022 we saw, I personally here at the site experienced a 50 percent staff turnover rate, which meant that about seven of the staff that we had had, and we do tend to retain folks at least you know, a minimum of three years. So we had this huge outflux of staff. And two of the seven were recruited by CROs. Two of the folks were relocations. Husband was relocating. They had to go. One retired. One returned to a cath lab setting. And one just changed professions altogether. And I wanted to share that mix because I think sometimes we think that as sites that a lot of this is in one direction or another. And I experienced this through all of those different things. So you know, having to, support the studies with this type of turnover was extremely difficult, as you can imagine. So, you know, a couple of the things that we had to do immediately were to literally pull back and say, All right, we've got to stop enrolling right now and assess our patients and follow up. Make sure that we have those patients covered before we open up any type of enrollment anymore. And of course, that's not what sponsors and CROs want to hear, but that is a safety issue that at the site level we have to address. And then I had to really look at, okay, what is my staff mix? Who do I really need on site here? Is there a way that I could potentially keep those two CRCs who relocated? One had eight years experience here at the site. One had five years experience at the site. And maybe make them more of a remote type CRC. And that's what I did. I, I really looked into that. We were able to make that happen. And they were able to take on not only assisting with, you know, non clinical type, just being mentors to all this new staff that is now hired. And also mentor the staff that was now existing and helping them, and doing anything they could that they didn't have to be on site for. So, There were a lot of other things we implemented, but I would say those were a couple of things that we really focused on just to get the ship righted and keep the patients safe, which is always the primary issue here at the site level.

Jimmy Bechtel 6:01

Thanks, Michele. And what I heard from that was that you had identified a variety of different reasons why staff was leaving. And we hear those reasons continuously brought up from our site partners, right? It isn't just I think the important thing there is isn't just one reason why staff is leaving. Coming out of the pandemic COVID affected the sites in pretty drastic ways. And that caused a shifting in a lot of different ways. But what I also heard that I think is very important for our sites to hear is that they're Was some nimbleness that was employed by your organization and thinking of new ways of doing things and how you can enable your site to approach staffing and workforce business model in a different way, which is great. Lindsay, did you have any perspective to add to that from maybe from the industry side of things and what you have heard and observed and how that affects ultimately, then maybe the work that Gilead is trying to do with the research sites.

Lindsey Morales 7:01

Absolutely. I've heard it quite a bit and I'll never forget. A couple of years ago, we started kind of hearing this, this rumble about resourcing and staffing and issues with staff leaving sites. And I remember thinking, we might have a real problem here and and coming back and talking to my senior management and talking to some of our study teams and just saying, look, we need to be very aware that this is going on. We need to know what our sides were facing, because what ultimately will happen is they're going to start having to pick and choose which studies that they can take on. They can't take them all because they don't have the staff or our protocols maybe a little bit more difficult than they used to be. So it was something that I specifically remember hearing about it and thinking we need to get, you know, we need to get in front of this because it's happening. And what can we do to try to stay ahead of it? And from from the sponsor and CRO side, I think what we've done. Is this ask that our sites be really honest with us and, you know, if you tell us that you're, you don't have the resources, or you can't do a study at this moment. It doesn't mean that we won't come to you again with a study or come back to you with the study. We do it all the time. But if you're up front with us, and you tell us ahead of time. That's exactly what we want. We want that transparency because then, you know, there's, there's that trust that we're building that. Hey, we can't do it right now. Hope to do it in the future. And we understand that we have we have the same issues on our end. Sometimes we don't have enough staff to cover studies, or some of us are covering 2 to 3 positions. So my advice to sites is to don't ever be afraid to say it. Don't ever, you know, try to say, Hey, Oh yeah, sure I can do it, but you really can't because you're short on resources or things like that. Please always be honest and, and let's see if we can kind of jump in this together and, and find a way to to fix this, this problem, find a solution and not just try to slap a bandaid on it.

Jimmy Bechtel 8:51

That's a great point, Lindsey. One of the things we talk about all the time is that transparency and communication and, and how important it is that that goes both ways, right? The sites talk all the time about how they want transparency, and they want revelations from the sponsor side to hear what's going on with the sponsors, what the sponsors are doing, what the sponsors are thinking about them, but also then that has to be a two way street. The sponsors need to be able to provide honest and accurate information back to back to those sponsors as well. So thank you for sharing that. I do want to talk a little bit about some of the ways in which we're taking this as an opportunity for our industry, because we know that diversity, equity and inclusion are really critical to what we are doing as research sites. And now I'd like to start with you on with this question. Lindsay is When we bring new staff into our organizations, and we bring new staff in at the site level, we feel that it's very important to recruit and train people with diverse backgrounds and diverse experiences. So how are you, and how are you maybe actually doing, but what are you maybe also observing the industry doing together to increase the number of on ramps into clinical research for people with diverse backgrounds and experiences?

Lindsey Morales 10:01

Well, I am very fortunate to work at a company like Gilead, who is all about diversity and inclusion. And we, we want to make sure that we're staying ahead of where we should be and doing everything that we can. And so I think from the site perspective, one thing that we're doing is talking to our sites, you know, figuring out, where are their patients? What kind of patients are they trying to find for a specific type of study? And then are we in the right community? Do we need to help find some staff that would help go into those communities? There's a different sort of areas where we can maybe assist in that we have different vendors that kind of can help us identify patients for certain diseases and things like that. But, but we're very aware of it, and we want to make sure that. Like, I said, we're saying ahead of it, not to sound like a broken record there, but it's absolutely true. And it's 1 thing that I love about working here. And so, when we talk about diverse background for for staff, I think everyone is making sure that we're including and again with our company, we want to make sure that we're hearing all voices. And I can't tell you how many people from different backgrounds that we hear about every single week. We're on discussions and phone calls and town halls. And I love that. So, I think, I think we're moving in the right direction. For sure on the sponsor and CRO side, I would say in the, the site side as well. But, we hear what needs to be done. We're doing it and we're hopefully doing a good job. We can always do better. But hopefully the site feel that and they know that we're here to support them as well in that in that endeavor.

Jimmy Bechtel 11:37

That's great, Lindsey. Michele, anything you want to bring up at your site that you're doing to help bring diversity and experience and background to your workforce?

Michele Cameron 11:49

Yeah, so for us here at the site, you know, 2023 was a year of what I like to call stabilization of staff for us which takes a lot of time. If you're trying to replace staff that's left, that is a huge undertaking. So onboarding had to be quick, efficient and so forth. ,We're a cardiovascular practice based site, so typically we're going to hire from the cardiovascular realm of clinicians especially for our CRCs. So we kind of broadened that a bit, that scope, and we looked at folks who had cardiovascular experience, for instance respiratory therapists, interventional radiology, those types of folks. So we didn't focus in so much on the credentials as the skill sets that we really needed to have in place. For them to be a good coordinator, whatever position we were, and most of them were for coordinator positions. So, so basically we had to go through hiring ten people to get the seven replacements. Three of them did not make it through their 90 days. So as we all know that, that happens, that, that is just something that happens that people get to the research site and they decide this is just isn't what I want to do. And then we just kept working that through those skill sets. And during the 90 day probationary period, and I do this typically meeting with folks every four weeks to see where they're at. Where are you at? Do you like what's going on? Because as you all know, it's very difficult to find trained research professionals. So, most sites have to have some sort of very robust onboarding program and start with the skill sets and then build from there. So the diversity came from the skill sets, looking at skill sets rather than At the typical person or credentialed person that we would typically

Jimmy Bechtel 13:46

that's an interesting and I think a really positive way to approach the situation, Michele. I also want to ask you a little bit about you know, the cost of recruiting and training new staff that you've seen because, you know, a turnover is a thing of life. It happens. We see it. Everyone has their turnover percentage that is their average or their normal. But when it goes beyond that, as you had mentioned, 50 percent is obviously not what a typical research site or a good research site would experience in a given year. So when it goes beyond that, how do you address the costs associated with recruiting and training and new staff and maybe provide a little bit more insight into how you address that entire situation?

Michele Cameron 14:27

Wow, that, that is just a, boy, that's a loaded question there, Jimmy, because it's as you know, You're tackling revenue side and expense side at the same time, because yes, you have this new coordinator. You're trying to teach them research. And in our setting, what we tend to do is set them up with a mentor trainer for at least three months. Because typically they're learning how we do cardiology as well as learning research. And they have to learn that in both a clinical setting and a hospital setting. So there's a lot to learn. And depending on what studies you have in house at that time, their learning curve can be shorter or longer. Because, as we all know, hands on repetition is how folks learn. So, if we are dealing with very difficult studies to enroll, it makes it more difficult to train a new CRC. So, as far as putting a number on it, I don't know what that number is, but it's, it's high. I can tell you that, profits between those years and what they had been were down a third. If you want to look at it as an overall number, it was a huge number. So again, we had to be very patient, had to draw from our resources in order to retain the staff we had, who now is overburdened because they're not only doing studies, they're training. So retain the staff we had and get these folks up and, and trained so that they could add to the revenue stream coming in. So it's a complicated issue at the site level to be able to do all that at the same time you know, and keep morale up and, and so forth.

Jimmy Bechtel 16:11

Great. Michele. And any insight that you can provide is fantastic. I think the point is that when we go again, beyond what our standard turnover rate is, what we plan for, what we're able to kind of churn through from a resourcing standpoint, it's a tremendous, and I would say exponential drain on your resources as a site. So thank you for helping emphasize that that point and speaking of the importance of it and also speaking to some of the solutions that you've been able to employ, right? You spoke previously to several different things that your site has been able to do. And same with you, Lindsey, several different insights into what you've seen sites doing. But I do want to begin to wrap our conversation up and I'll start with you, Lindsey, on letting our audience Of sponsors and CROs know some of the action items that they might consider based on again, our survey results and maybe also sharing some insights into some things that you know that are available through SCRS or through you as someone in charge of site partnerships. And then I I'll go to you for the same perspective, Michele.

Lindsey Morales 17:16

Sure, I was just in an investigator meeting not long ago and we were talking about, when you are staffing a study, how much goes into it and how much time and energy and how some of our protocols have become a little bit more difficult and how we're asking so much of our study coordinators, which is near and dear to my heart because I know that we're asking a lot. And, and more so than we have in the past. So I think on our end, when we talk about retaining staff, I think we have to be aware of, you know, that fatigue and that burnout that that may be some of our staff at sites are experiencing. And so From the sponsor and CRO side, we have to be aware of that when we're writing protocols and we're talking about expectations and how many, different portals we need them to sign into and things like that for all of our studies. I think all of that really feeds into it. I know, there's some question around. We do recruit from sites. I know that's always a frustration and that we see, but to be honest with you, I've been seeing that for 19 years. So I think the best that we can do is just try to work together, try to collaborate together. I think the sponsor and CRO side understands the frustration on the site side that we are pulling so much staff from their locations, and so, you know, it's a little bit of a dance that we do, but we're trying to figure it out. And I think that we're aware that we're hurting ourselves somewhat too. And we're, we're pulling staff from our sites that are doing such a great job for us. So, I think really, it's just listening is the best thing that we can do and make sure that we're. We're doing everything we can to make it as easy as possible for our sites to be honest. And because we want to continue working with them, and we want to make sure that they feel like they're, they're being supported as best they can. And we're not putting more on them than then we should be.

Jimmy Bechtel 19:02

It's a great point, Lindsay. I think listening and taking action on the needs of the sites, as you had mentioned, is all that the sites are asking of the sponsors and CROs at this point. So great point. Not one of those ones that can be emphasized too many times. So thank you, Michele. Any perspective on your end as, as what we would see as action items that we ask of our sponsors and CROs, but then also maybe resources that we could make available to the sites.

Michele Cameron 19:30

Thanks, Lindsay. Yeah, so a lot of different things. Right now, we're more in the retention mode of keeping staff and so forth. And our model here at this site is that the CRC is central to everything we do. Everybody is administrative to the CRC, including myself, by the way. So by doing that, we really focus on what the CRC's job is and what they need to do to get their job done. So we've hired a lot more support staff to do things like faxing, labs, data entry, those kinds of things, because we really want our CRCs to be those patient facing people. They're the ones that need to be talking with the patients, assessing them, those skills that they're very, very good at. So we really had to take a good hard look at that and by providing them with more flexible schedules competitive benefits, all those things it, it has really helped I think. And just having an open dialogue all together, the stay interviews. We've always had performance bonuses built into what we do, and here at this site, we do it as a team versus individuals, and I know people do it in different ways. So, these are some of the things That we have done internally to help retain staff and, and again, readjusting the workloads as well. And the workloads, when I say workloads, based on the number of visits people are doing and how difficult those visits are. Some visits take, as you know, can take two hours. Some visits can take 15 minutes. So just being very acutely aware of the workloads that are on individuals and making sure they are spread out. More equally, so to get it done as a team. And I think that you know, I think that the conversation is out there between the CROs and the sites on, you know, we can't be competing for staff that we've really got to find new ways to educate newcomers into the field, and I've seen folks working on that, and I think that's wonderful. But yeah, if we can, again, keep the on site recruiting, if you will, you know, when monitors are on site and, and they're recruiting, that kind of thing, which I know has always happened in the past, but keep that to, to really a minimum so that they are, folks are going through other channels. If they're looking for other work, then go to, a recruiter or go to a website and, and find that way. But the actual on site recruiting, that that part should be addressed and and not be happening because it just undermines the fabric of the trust between the CRO, sponsor and the site.

Jimmy Bechtel 22:18

I couldn't agree more, Michele. I think it's a great point for us to conclude our conversation on today. Michele, Lindsey. Thank you both for being here with us today and sharing your perspectives and reflecting back on some of the data that we gathered out of that survey. I think it's extremely valuable for us to continue to have these kinds of conversations. As we know, this isn't going to be a problem that is solved overnight and really does take the entire industry coming together and realizing everyone's perspective to be able to work towards a solution on. So, Michele, Lindsey, again, thank you for being with us today.

Michele Cameron 22:52

Thanks, Jimmy. And thanks to SCRS for providing all those tools for the site, the workforce task force toolkit. Wonderful. Wonderful. Lots of ideas in there.

Lindsey Morales 23:05

Thanks for the plug, Michele. Yeah, and thank you. Thank you for including including the sponsor and CRO side. We appreciate being part of the conversation and we appreciate so much of what SCRS does. So we're happy to be here and continue working with SCRS.

Jimmy Bechtel 23:20

Well, again, thank you both. And for everyone listening, make sure that you register for upcoming summits where we will have more conversations around topics like workforce and many others. Being held throughout the year by visiting the summit page on our website, my SCRS. org. While you're on our website be sure to check out other SCRS publications and tools like the workforce task force toolkit built for the community and the publications and member resources section of our website. We appreciate everyone's listening and participation to today's program. I look forward to having you join us for more great content coming out soon. Thanks again for listening.