The Hole in the Middle: How Site and Sponsor Relationships Suffer with CRA Turnover - Ashley Margo and Maria Milas

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HANNAH LIPPITT: Hello and welcome to the Totally Clinical podcast brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and, most importantly, the people benefiting from clinical research. So, tune in,

settle back and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT: Now, clinical research is experiencing a serious shortage of staff in a wave of resignations due to several factors, such as long hours, a lack of resources and better pay elsewhere. Here at Totally Clinical, we feel it's important to shine a light on this topic with a specific focus on CRAs, who play a pivotal role in clinical research. In this episode, I'm joined by Ashley Margo, remote site monitor and founder of Clinical Research Circle, along with Teckro’s Maria Milas, a former CRA and

senior manager of site engagement.

Today we are going to look at the role of CRAs in greater depth – what is leading to burnout, and the impact this could have in the future on clinical research.

To start, let's level set the role of the CRA. It's a crucial role in clinical research, but CRAs are often the unsung heroes. Can you both describe the importance of CRAs, starting with you, Ashley?

ASHLEY MARGO: For CRAs, I mean, everybody on the study team is extremely important, but I would say CRAs specifically because they kind of do the in-between. They get to go on

the site, have that personal contact with the actual site staff. They can make that relationship with the site staff, the trust and also building that connection right between them and the CRO and ultimately the sponsor. But it's to help really ensure that whatever we are receiving on the CRO end for the study data – I mean all sorts of information that the CRAs going in and kind of assuring that everything is accurately being filed, documented – and should there be any questions or anything like that the CRA goes in and helps teach obviously the site coordinator, the PI, and like I said, just kind of being that glue in-between.

So, it's definitely correct what you say: CRAs are the unsung heroes. I myself am a remote, so I work with on-site CRAs and it's extremely crucial in order to be able to accurately be able to push all the information that is necessary from the site to the CRO and to the sponsor that both the RSM and CRA work together to make it a really great 360 teamwork.

MARIA MILAS: I definitely agree with you, Ashley, it's, I like to think of the CRA always, as I call it, a quality filter, the filter of everything that happens at sites – it's going to have like a check, a second check, an external eye was going to come and check, maybe not only the data that's being generated, but what about the

equipment? What about the documentation that's being filed? All the correspondence, the relevant correspondence that's been sent from the sponsors and from the CRO, even from myself as a CRA to the site. Is it filed? Is it still there? Is the staff that are working on the study, are they trained? Are they up to date with all the certifications. All those things – they all go through the CRAs. So, I call it a quality filter.

HANNAH LIPPITT: Now, both of you have been CRAs. What attracted you initially to the role and how have you seen the role change, if at all over time?

MARIA MILAS: I would say that I definitely started as a CRA because of an altruistic need to, let's say,

contribute to saving lives. In my case, I don't come from a scientifical background, so I've always wanted to: “How can I help the industry? How can I help the research, the investigation, the bringing drugs on the market, and how can I help patients to have access to that?” So, that was the reason that I got into being a CRA starting, of course, of being a clinical trial assistant and then getting some training and some certifications on monitoring clinical trials. But that's how I started, as simple as that, plus always having an interest in research and investigation. Now, how has that changed? Well, I would say that over the years since starting, that motivation is always there. I always kept it. And it's always what makes you go through all of the challenges and all the stress that you have on a daily basis as a CRA. But then at some point, you're also considering what your current lifestyle is, what the quality of life is. We focus and we care so much about the patient's quality of life and clinical trials, but then at some point, we also think about ours, especially with time. So, I think that's what I've seen changing a little bit more over the five years that I was a CRA.

HANNAH LIPPITT: And for you Ashley?

ASHLEY MARGO: For me, in regards to what initially attracted me, I was a pre-med student and as time kind of went through and I kind of did about 200 and some hours shadowing hours

in different specialties, I kind of realized that that wasn't for me, but I did know that I enjoyed being at the site, I enjoyed being at clinics, I really liked to assist people – kind of like Maria has just said – I really wanted to still have that access and I remember doing a lot of research and not finding the in-between. And then when I came to clinical research, initially, I saw the clinical research coordinator role, but then I also understood that I kind of wanted to be more at the level of which I had access to the study team, where I could grow and ultimately be part of the change, on a higher level. And so, I came across the clinical research associate position. Fortunately, at the time for me, I had just worked in COVID-19 for the state of Texas, and I was working remote for the past, I think two years. So, I ended up transitioning into a remote site monitor role because obviously COVID, I wasn't looking to travel at the time. And so, it just worked out really great for me. I got to obviously speak with the PIs, with the site coordinators and along with the study team. So, it gave me the best of both worlds on my end. Also, the opportunity, right? If I ever actually want to go back on to site, I have that option, but as time has passed, I've become, you know, a co-founder and a founder of other organizations. And so, it just works out for me now to still stay remote and not travel, because travel does take a lot. There's a lot of things that go into being a traveling CRA. And so, for me, remote site monitor is really what worked out the best for me because I get to have the work-life balance, you know, I get to be home, I get to be with my dogs, my family, and also maintaining, you know, sometimes what might be a very busy-paced environment for work and still be able to handle everything at the same time.

And what things have changed? I have seen internally how I think because of COVID, we've seen how there are different types of individuals that are wanting certain things or wanting to be on site they're wanting the experience of travel and/or they're wanting the flexibility of family time and all those kinds of things, so I believe the industry is taking notice of that and ensuring that they're able to retain talent, right, while also being able to execute what is necessary/needed for the sponsors. So, I'm seeing a little bit of, I guess, leveled-out positions for both on-site CRAs, remote site monitors as well as in-house CRAs and monitors that actually are willing to travel as well. So, there's a lot of hybrid changes going on and I think that's actually a really big benefit because I think ultimately that is where the industry should be going because, you know, if you're going to want to bring on talent and retain talent and ensure that we're making sure that those individuals are also well trained and they stay with the company, they have to be able to bend to the needs of those that are working in the industry.

HANNAH LIPPITT: Ashley, it sounds like it was a really positive transition for you. You really made it work for you, being mainly remote. And also, the industry is obviously capable of reflecting and shifting. Now, Maria, we've talked on the podcast before, and I know that part of the reason you decided to leave your role was because of travel. Could you explain more about this?

MARIA MILAS: Being

at home – the time of being at home as a CRA – is luxury. And I remember that at one point I was monitoring seven clinical trials at the same time; they were all for the same sponsor, so that helps, but in the end, if you have at least, let's say, three or four sites for each of those studies, you travel at least four days out of five, which means you can be waking up at 3:00 a.m. to take a flight because you've decided that you would love to sleep home in your own bed that day, or you can just do those four days and sleeping at hotels and traveling from one site to the other and then coming back at the weekend, right? But the difficult part from traveling so much is, well, of course, on one side, it has a toll on your personal life, right? There's making plans with friends: that's not an option unless you make plans for the weekend. Or as Ashley said, I get time to spend with my dogs. You can’t think of having dogs. You can’t think of having a family, kids. Of course, not as a CRA. The most stressful part as a CRA is because you're traveling so much and that travel time is usually not, let's say, it's not time that you can spend working because you most certainly will not have connections, so we won't be able to do that monitoring with this report or that follow up or that site management activity that you need to do. Still, for the other sites that you are not monitoring that week, that means that when you get home on the Friday, you will still need to catch up with a lot of work. And usually that meant that on Saturday, on Sunday evening, I would be doing monitoring visit reports so that on the next day, Monday, when I'm back going to another site, I don't have so much work to catch up with. So, that's the burden. That was the burden for me as a traveling CRA. The problem itself is not traveling, it's just your time, your performing time, your activity time, your working time is reduced to almost a minimum because from your, let's say, 10 hours working on a day – because if you're traveling or you're on site, it's definitely not going to be an eight-hour day – it's going to be much longer than that. But your useful time is maybe, let's say, four or five hours, and if you want to prioritize actually what you need to do and what's your priority as CRA, which is monitoring clinical data, then there's so many more activities that are left in the background and that you will still need to catch up with probably on a weekend. So, I would say that was my reason to consider not being a CRA after a few years, because as I said at the beginning, the lifestyle that I was having at that moment was completely on the road, whether it was on a flight or it was on a train or it was on a bus or driving somewhere, but then it's also a toll on your mental health, right? Because it's so much stress, it's so much burden, and it's on a daily basis that even considering taking vacation, it's going to be stressful because, you know, all the things that you need to catch up with when you're back. So, that's sometimes why every time I talk to my previous colleagues, most of them are not CRAs anymore. It's always because of the same reasons, because of the stress, because of the long working hours, because of the weekend hours, because of the traveling time.

HANNAH LIPPITT: It's really interesting because so many people see travel as like a bonus of a role and are actually attracted to jobs because of the travel options. Obviously not in this case though, but the industry’s more flexible approach could surely help address this issue. Ashley, Teckro staff wrote a blog recently about the Great Resignation, if we can call it that, of CRAs and other site staff.

What do you think about the points raised and why do you think this is happening now?

ASHLEY MARGO: I think it's happening for multiple reasons. I mean, one big elephant in the room is obviously the economic situation. Since COVID, there's been lots of ups and downs. A lot of individuals are affected, and this is not just individuals that are kind of, you know, let's say, at the lower pay grade. I think everybody at this point is feeling it on the floor. And so, companies and not just this industry, but just in general, they need to be mindful that the workload needs to equate to the pay. Because it's just like Maria just mentioned when you're talking about the job and then you're talking about what comes along with a job – so you know that you have the travel and then outside of that, you have to continue to work kind of breaking into your family or and or, you know, living lifestyle – some individuals may feel like, “OK, this is worth it because I'm helping individuals and also because financially it's situating me and situating my family, it's creating this good environment to where I can actually move forward in the future,” all sorts of things like that. And so, when you have a scenario where you're doing all of that work and then the pay, for instance, is not at the same level, you know, you start to feel burned out. And aside from that, it's also again the CRO or the sponsors’ responsibility to meet halfway and understand the perspective of the, you know, the individual, the professional. It’s if you have a scenario where these individuals are really great, they're very experienced but they're getting burnt out because they don't get to have an actual social life, what are you going to do to meet them in the middle? I do feel that there are changes in the industry, as I previously mentioned, where they're giving more opportunity for remote and things like that, and I've also heard of companies working towards instead of going to extreme travel from one state to the next, they're keeping you within your region so that it's driving distance. So that it's not literally affecting you extremely. Those are really great changes, I just think that there has to be a lot more collaboration with the internal employees and professionals to kind of see what would work best, you know, to really help avoid continuous resignation and/or jumping around, because really, I think that that's also what's happening. You're getting recruiters from other companies coming in poaching, right, to say, “Hey, well, you're getting paid this,” or “We can pay you much more.” So, I think it's meeting the idea of having competitive pay, but also trying to understand that pay is also not the entire factor. It's the work-life balance at the same time. If you can keep your employees happy, they will stay, so, it's finding out, maybe providing two options. Who knows, you know, more pay or more flexible timing, something like that, but every individual is different. It's not a one-way street for everybody. And in doing an understanding this, you know, I'm hoping that there's going to be more alternative options for individuals, because obviously we're in research. Quality assurance is absolutely important. But in order to do that, you need really great trained professionals that are not just well trained but also feel purpose with the work. So, if you don't feel purpose and you feel burnt out, it's not going to be there, right? And so, as long as these companies can see that and maybe take some acknowledgment of it and make... work towards some change, I think there's some really good things to look out for the future for CRAs.

HANNAH LIPPITT: So more awareness of employees’ needs, more flexibility, a less rigid approach. This always seems to be the way forward with employees. Maria, what are your thoughts on why this situation is so important right now, it's really coming kind of to the surface? Do you have examples of people you've worked with who maybe are following the path you did and now leaving the industry?

MARIA MILAS: Oh, definitely and well, it all comes from, let's say, several things. But one is, when you're a CRA, you have maybe 20 or 25 other CRAs in your study internationally that are working with you. But then in the study, maybe you have two or three study managers. So, you know that for each study, let's say from 25 CRAs, you'll have two or three study managers. So, your, let’s say, probability to become a study manager when you want to not only step up but make a change in your career path is already a little bit more reduced to a minimum. So, sometimes CRAs feel stuck of “What am I going to do next?” Because if there's not many study manager positions, there's not many opportunities for me because we would all want at some point to be a study manager. The other teams inside, let's say, whether sponsor or CRO, let's say, maybe regulatory affairs or maybe study startup teams or any other team, they're even smaller than the clinical operations teams as per se. So, sometimes as a CRA, you feel stuck in your career, but now for me, my change to Teckro – so to tech, has been one of the best changes that I've done and I've seen that in some of my friends that were CRAs as well, because it still fulfills that need or that desire to still contribute to bringing drugs on the market, to still contribute to saving lives. But at the same time, you have a better quality of life. So, I've seen former CRAs who are now maybe subject matter experts in tech companies or they’re clinical information designers. So, there's all types of roles in tech or even at sponsor or not even tech, but let's say that the tech industry now is huge, right? It's growing. It's developing so much in clinical research. So, there's definitely a lot of position, roles, a lot of variety that the CRAs now have access.

HANNAH LIPPITT: I'm getting the impression that the CRA role is quite a transitory position. If it continues to

be a transitory position instead of a long-term career path, what do you think this will mean for clinical research?

MARIA MILAS: It has a lot of impact on the sites, on the sponsor, on the CRO and on the data that gets generated in the clinical study as well. Because if you get changes and newer CRAs on a regular basis on a study, it's going to be harder for the sponsor to create a relationship with the sites because the CRA is, in the end, the image, the person who represents the sponsor or the CRO when you get to sites and the sites are used to knowing, “ok. So, Maria, is my CRA for this study. So, I relate, or I know that this person, whenever I have a question for this study, is going to be to this person.” So, it's going to be more difficult to have them engage with you as a sponsor if every time they have a question, they don't know who to go to or they don't know, “who is the face, who is the person who represents this study?” And then there's also going to be an extra burden for the sites, right? It's extra confusion: “I need to figure out now who's the CRA for the study? Who I need to reach out to? Do I have to go back to my last email for the study to see if there's any changes in the CRA? Was I informed? Was I not informed?” Sometimes CRAs just come to the sites for a monitoring visit. Maybe they were informed that there is a new CRA, but because the sites are stuck with a full email inbox of unread emails, they didn't even know there is a new CRA, so when they pop in, there's like, “Who is this?” So, it creates a little bit of confusion as well. And then, of course, from the, the data that's being generated in the study, the more junior CRAs you have, there's going to be a higher probability to miss something because you don't have trained eyes that are going to check that data, that are going to check those certificates, those calibration certificates, those ranges, those medical records and maybe even practical deviations are a little bit higher in

the study because you didn't spot them at the time or you just didn't have yet that trained eye, that experience, that a more trained CRA will have.

ASHLEY MARGO: To add to what Maria just said: I think that in itself is very prominent of an issue, but even more so the long-term effect, on the data, on what'll happen to all of that as this study is going through, you'll have junior CRAs coming in and, you know, they might have to extend more continuous visits, ultimately putting stress on the site because they need to, you know, really get to know the site and probably sometimes even jump back x-y-z certain visits to kind of get on par with what's going on with the site and/or to get on top of ensuring that there was no errors before they initially start their continuous visits. There's also the scenario of, you know, junior CRA also not doing that and just continuing on, assuming that the previous CRA marked up everything that was needed and ultimately missing things and getting an audit and having issues and then the site getting marked, right? There's so many things that can come up out of that, which is, it's unfortunate, but it's very true that ultimately we could be left because of the movement, the CRA position can actually do not just within the industry but external to like tech and all sorts of other areas, healthcare, sponsors and CROs need to be fully aware of this, which I'm sure they probably are but because of that, you know, finding solutions in between that because they have continuous junior CRAs coming in it, there's a lot of downside to that. Especially if the training is not thorough, which for me, on my perspective, my end, because I also have the University of Clinical Research that I helped found, I'm aware that not all companies have great training systems. That's just, it's a known fact that they're not really great training systems and so that's obviously an issue, right? Because you have these sites that may be even new when you, let's for instance, let's talk about diversity, we are so focused on diversity and inclusion right now so we're wanting to have these new PIs get into research in these rural areas, so they're depending on these CRAs to guide them accurately so that they can have their first few studies go well. And so, imagine if you have a junior CRA and the PI not know that and the site having full trust in that CRA and you know, an audit comes along and they get a first marker, you know, that could actually deter a diversity PI from a rural area which we need to remove himself from research altogether because it was a horrible experience. So, there's just so many factors that can play into this that I'm hoping that the industry is working towards kind of filling these gaps, that can potentially create these

situations.

HANNAH LIPPITT: The subject of CRA burnout is really one that needs to get more attention, the problems that a shortage will cause and what the industry needs to do. So, thank you very much for joining me today, both of you. It's been so enlightening learning about the reasons for CRA burnout and your personal experiences of course, and I look forward to speaking to both of you in a follow-up episode, where you'll go into greater depth about how you can

make the CRA role more appealing by rethinking daily responsibilities and leveraging technology to hopefully reduce the pressure.

MARIA MILAS: Thank you, Hannah.

ASHLEY MARGO: Thank you.

HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review so more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!