Solutions to Combat CRA Burnout - Ashley Margo and Maria Milas

You Yeah. So you should see the Record button. And I think the cooking has been turned off now, too, so. OK So, um, I'm going to do the introduction in 3 O and the mute saying if you remember the meeting while I'm talking here, and then I'll meet you guys and then.

I don't always think I need to say Ashley or Maria. You know, you can kind of pass among yourselves as well. I mean, I was also I was also thinking that we can also pivot between ourselves. Right I can also say I really do relate to what I'm saying.

Yeah yeah, Yeah. Is that your stance as well? OK cool. OK, so, three, two, one.

Hello and welcome to the second part of a two part series on clinical research

associate burnout. Now last week I spoke to Ashley Margo remote site monitor and founder of clinical research circle, along with Chris Maria m.s., a former Sierra and senior manager of site engagement at Tech Crew. We discussed why the clinical research associate role is so pivotal in the industry, along with how the roles changed over time and the negative long term impact of burnout on the industry.

This week, we're going to delve into some of the solutions to attracting and retaining

high quality candidates by discussing jobs processes, by discussing the tools, processes and training necessary to reduce pressure and increase job satisfaction. The topic of cry burnout is key for the future of the industry and for all of our health. So all of us should be interested in the well-being of Cirrus. So I hope you enjoy this podcast today.

Welcome back, Ashley and Maria. Thanks so much for joining me again. Thank you. Thank you.

Good to be back. Now, Ashley, you have an organization, the University of clinical research, which helps students train for jobs in clinical trials. Could you explain more about some of the solutions you've explored that could help with Cre burnout? For sure.

Well, again, Thank you so much for having me back. It's great to be here. So, yes, as you mentioned, I'm the co-founder of Latinos in clinical research and also for the University of clinical research, both which,

you know, help bring knowledge to students and our members, new and old within the industry of the University of clinical research is where we train on multiple levels. This goes from clinical trials, systems CRC series clinicians, medical writing, data management, et cetera.

And so ensuring that students, you know, are more mindful of what the positions actually. Intel right. I find that some of the issues that we come across, especially for speaking zero sponsors and other vendors that work within the industry, is that a lot of times the language between the actual HR. And Darb documentation description along with, you know, the actual individual, the manager that is looking to hire for that particular role.

Sometimes the communication is off putting. So when you look at the actual job description, it's either vague or it's very detailed and it's not fully aligned to what they're looking at and/or where the limitations start and finish. Now, we can maybe jump into that a little bit later, but nonetheless, so having specific tools and processes in place to help break down the burden of the workload and timing in which the workload is processed, is super key, is. And not only getting somebody into getting interviewed and getting into the position, but also ensuring that they make it through the actual 90 day onboarding system.

Right because not, you know, you may get the position or get an offer later, but doesn't ensure that you're actually super fit for the role as you're going through the onboarding process. So getting exposure to clinical research systems is, is extremely, extremely important exposure to organizational tools such as OneNote outlook, all access of outlook version communication systems such as office charts, et cetera those kinds of things are extremely key, I feel, because of the fact that when you're onboarding, not only are you having to know the knowledge, but you're also having to understand these systems.

And usually when you are getting to the knowledge to the onboarding and also having to train for systems, it can definitely be, you know, mentally and, you know, physically stressful, you know, in individual because it's just so much information being thrown at them. So anything you can do to really bring down that burden before on board is, I think, crucial. I know. Mario, do you think?

Oh, yes, I actually I was going to say, I'm so excited when these type of initiatives come on the market for a series, because if I go back to when I started being a Siri actually when I started in clinical

research, I was a so clinical trial assistant, so I was a support write for Sierra who went on site. During that first year of being a CTA, I was glad they suggested it was a great advice to take a master's degree in monitoring clinical trials, at least here in Europe. It is very recommended to do that if you don't come from a very scientific background. So you either have a.

Clinical research, or you do one of these master's in monitoring clinical trials. Now, if I am very honest, during that full year of a master's degree, I don't think I touched or tried to or saw from the inside any of the systems that later on as a theory actually used. So I remember learning what a ktm's is, learning what an EDC is, learning what I WRC but I never saw one. I never got to experience one.

How do you navigate in it? How do you actually adaptation? How do you monitor a patient? How do you open a query?

How do classically which types of graduate clothes, which are the different roles that are involved in these systems? So I am very happy and I honestly congratulate you for this initiative to bring series on board and not only teach them and show them, but let them play with these tools. So that they're better prepared for when they get into a survival.

You now when we in prevent change, challenges inevitably arise if some of these solutions are introduced.

What kind of industry obstacles pushback do you think you could come up against? Maria oh, well, Hannah. We are creatures of habit, isn't it? So we.

We, we, let's say, invest so much time into learning these tools, into learning how they navigate. And if we are very honest, most of these tools, they're not user friendly. They're not easy to learn. They require huge amounts of time being invested into training, into getting the certificates.

And not only at the beginning, I can think of several of these tools that require you to constantly be trained and update those trainings because those certificates are needed. So of course, when we introduce new technology tools and new software tools and new resources, we're a little bit reluctant not only as an industry, of course, as an industry as well, but as an individual and as a career as well. Because you're thinking, oh, my god, I am, let's say, monitoring seven different clinical trials at once. And if in each of them, I have different tools, hopefully not.

But if in each of them, I have different tools, I need to constantly be doing trainings. I can I have to dedicate, let's say, one full morning every single week to the trainings on one of these softwares. So if, let's say the study introduces me with a new tool, of course it's going to be an obstacle because in my mind I'm already thinking, Oh no, a new tool that I need to be familiarized with. So my reaction will be a pushback and initial pushback.

Now we know that technology is our friend. We know that in our personal lives, it's let's think of the easy communication tools that we use, the instant communication tools. It allows me to be in constant contact with my family who are living 3,000 kilometers away from where I do. Right so technology is our friend.

We can see otherwise. But if we can make it somehow just easy to implement user friendly, not too much time. Ideally, when no time required to do trainings, those pushbacks will be minimum. And once you get to be exposed to it, you have a flavor of how it works and how it helps you, how it, let's say, isn't the burden of your daily life.

Well, we'll all embrace these tools because those

are the tools that will help you just deliver a better result and be better at what you write about. Your goal is. I 100% agree with you, Maria, and I love that you bring that up because it definitely gives I would say, you know, the, for example, Kerry employee perspective. And I think in scenarios like this, it's extremely important that you get both sides right, not just the employee, but also from the organization side.

Right because the organization also wants to be competitive. So these updates need to happen. These changes have to be implemented. I would even say yearly to be reviewed because again, if they want to be in the best and they want to employ the best, they need to always be having the best technology, the more innovative technology, things like that.

Right and so I think it's important to consider, you know, we're talking about the burnout four series and understanding, you know, the kind of burden that plays, but also the role of the crew on that end. And this is why, again, why the University of clinical research, why we think it's important that we partner up, especially, you know, for example, with your organization to get to know your system, to give exposure to these. Sierra's on that way before. And in advance because once they jump into Sierra, it's almost guaranteed that every year, if not every six months, they might be changing or having to update on their end the multiple systems such as the one or two or three.

I mean, for me, I work with 5 to seven different systems. I personally, when I got on board, the onboarding was extremely difficult solely because of the system part, not because of the knowledge. And within six

months we were already transitioning to a new system. And I remember the only irritation that I had was that I just learned the system, you know, and now having to relearn another one.

So if there's a way for Sierra's to understand that aspect that, you know, to help kind of push off that, you know, a burden, but also that kind of percentage time frame as to where somebody can actually make an error or mistake if you give that exposure in advance prior to the onboarding. Right or partner with organizations that do that. Right, you can definitely help kind of ease that side part when you're transitioning. Why?

because we know that if somebody knows at least three systems, obviously all systems are not the same. But if you have a basis right, it's much more easier for you to transition into your systems. So again, y you know, I think it's important to consider, you know, burden and and overstress of a Sierra and whether the new or have been around for quite a while because I think one of the biggest ones is a system. I mean, my organization, we're prepping for a new system change and I'm dreading it because I know that there's going to be a period of transition.

And know, it's going to bring down my efficiency probably by 20% or 30% Right and that means I'm going to have a more max capacity on workload. I'm going to have to prepare for more stress. Right and that's that I'm already experienced. So imagine somebody that just got hired and has to go through that period as well.

It's not it's not good, you know. And so those kinds of things are I feel like the pushback for Sierra's or organizations is wanting to work with people outside of their know, I could see the sphere of connections, but if there are people out there working on these different technologies, innovations like your organization, like our organization and finding ways to collaborate right and give this exposure in advance and not be the word that Hannah used. Right kind of pushing up against it instead of working with it. If they work with organizations

such as ours, I feel that there will be a more ease into these transitions and all those kinds of things.

Maria and Maria. In the last podcast, in part one, you touched on how Sarah travel demands aren't really as much of an issue as sponsor, crew and c.r.a. coordination. What kind of solutions would you recommend to help this situation to improve communication? That's a great question, Hannah.

You know, when series starts or when you're a junior, Sarah, you're so excited about the traveling aspect because you're thinking, oh, I'm going to know so many new regions in my country. I'm going to even know so many new countries that I haven't been to. Investigator meetings, being in different countries, sometimes even meeting the sponsors can be in different countries. So it's you're very excited when you start.

It's definitely not an issue. We want to travel. We want to have that active lifestyle because the areas are usually that the type of personality that want to just go back and forth to just wake up early morning their early birds, they want to be proactive. They want to be high-performance roles in clinical research.

So that's never an issue when you start at the beginning. And I would say the traveling aspect keeps not being an issue by itself during the sera experience, however, that travel time. So let's take a monitoring visit, for example. I can I used to be based in Barcelona.

So let's take a simple one, a simple monitoring visit to Madrid, from Barcelona to Madrid. So I would take a train that was three hours and that would, let's say, make a total of four hours to getting from home to the site. So maybe I would take the six day flight so that I would arrive by 10 outside, which is already a good amount of time, a good time to arrive at the site, because in the end, the investigators might be still in their morning session. So by the time I arrive at 10:00 AM is just that it's good enough.

OK that's four hours in which I would try to be, let's say, productive and do work and maybe update my DMs or maybe write my monitoring busy report of the my dream visits for the priority. However, if you need connectivity internet connection to do those things and you don't have that during your trip,

that's a time that you cannot use to work, right? It's kind of time that it's lost. It's great because you can have a nap.

You can catch up on those lack of sleep, or you can read a book or you can relax a little bit because your day's already going to be stressful enough when you get on site. But still, that means that you are going to need to catch up on all this work. Now when you get to site, there is a lot of communication that needs to happen with your study manager or even with your CTA, right, with your clinical trial assistant, because you might be on the side and your study manager might say, hey, Maria, can you talk? If you investigate, you can sign this.

Can you check if this document is there? Can you please just print this and make sure that these relevant. Who are trying to focus on your activity. During that visit you have constant communication that needs to happen instantly with your study team.

Imagine if each of those questions are coming in by email. Those are at least 1915 emails that come in to your inbox on the day that you are doing my dream visit and you need to focus on one. Monitoring the data, speaking with the investigator, going through the queries and questions. We study coordinator, going to the pharmacy and monitoring the pharmacy data.

And my advice honestly, it would be one use tools that during the traveling time you can use offline so that I can be productive, so that I can write those reports, so that I can report those deviations, so that I can do that follow up or I can do those site management activities offline and have a tool, a communication tool that allows me to immediately, let's say, easy and immediately contact with my study team or with my trial assistant or with whoever I need to work, but

immediately. And it shouldn't take much time from my monitoring visit. Otherwise, you won't be able to complete your monitoring data for the day and you will need extra time, an extra monitoring visit day which increases the budget, which also makes you need to catch up on work that you actually couldn't do because you had to extend that monitoring visit.

So those would be my, my, my two types of advice to basically just get the most out of this time. Well, I completely agree with Maria and me on my end. I think it would be a lot more focused again on zero perspective. I think they need to be more specific in the job description.

You know, as Maria stated. She she mentioned that, you know, there is when you're a junior, you're kind of infatuated with the idea of traveling. I mean, that was kind of my situation. I was just very fortunate enough that the position that I was initially offered was remote.

I wasn't too happy with that in the beginning because I wanted to travel. And luckily, like I said, everything happens for a reason. So when I got that role, I got to see exactly what that entails for Sierra. And I'm very happy that was not the initial route that I took because, again, you know, when you have a description.

And when you have a notation on the job description of the percentage of travel, I don't think people really are able to fully break that down, especially those that are barely entering. They don't fully understand what that entails. And I that's also why they specify a percentage, because there's no way to automatically know exactly what role that theory or what study that Sarah is going to go into and how that monitoring plan is going to look like, how often they have to go to the site. But yes, definitely giving an example, you know, two or three times a week or month, however many times they're going to travel.

So that they have a full understanding of what that is. You know, I would even suggest, you know, obviously, this would be a company that would go the next level, but maybe even providing a little watched video about, you know, ocr, talking about what their travel looks like. Right so getting a clear view of what's going on because, you know, when you're considering travel, it's not just that time frame from 8 to 5, right? It's everything after that.

And eventually you have more work, you have much more time. And then your what PTO accrues right up. And and, you know, once you take that time off, you really can't when you come back, you have all this work, right? And so it's just a lot of back and forth.

And I believe we spoke on that a little bit on the first video. So I think it'd be helpful if the organization would do multiple options. For example, maybe doing long distance travels through state of countries for those that are open to travel just far. And then the option of short distance travels

for those are only OK to travel within the region.

For example, you know, I'm from Austin, Texas, so it's a pretty big city and a lot of neighboring areas. And so I think now if I were to be traveling Sierra, I would only be OK to opt out for that to where I know exactly how far these areas are so that I can feel a little bit more confident about my work time management. Right and then for remote work, obviously for experienced and unexperienced incoming series, this will allow room to get to know the role and decide how far they'd like to travel. Right, because some are still OK with travel long distances, even considering the time work great.

So just having be more flexible with options. So that you can cater to all sorts of lifestyles and people that are open to different things. And I feel that this will not only, you know, bring down the I guess I don't know the exact word term, but it's the loss of Sierra's right, because you have the overburden and then some of them just drop out in general from the industry and/or those that are leaving to other organizations that are being a little more clear and/or offering them more money. And then being open about, OK, now that I know exactly what travel is, I'm only willing to take this, this and this and being more open about specifics when it comes to their role.

Right and so

I think having these different options not only makes it flexible, but it also gives room to for the CRC to openly discuss what changes they would want for themselves. And that I feel like would make a more work life balance and the organization would ultimately also create a relationship with her. Sierra's this way because they feel comfortable having that conversation and feeling open and accepted with their particular lifestyle experience what they'd want. Do you guys feel that we've touched on?

You know, the question is what tips and advice would you give to sponsors and ceos, do you think? We've kind of covered some of that. Yes I do live in exactly the. Huh?

well, yeah, too. I had only one thing in my I don't know if it's relevant, but for me, it's your theories. Don't decide on which tools you have if you don't ask. So maybe I can just added as a to actually if you want.

Kind of. Yeah I mean, I'm thinking so ask a series and also you want to talk about working closely with organizations. So maybe I could say. Do you have any tips?

Yeah like and I think rather than saying some of the tools and technology, I'll say what key piece. If you could give them one tip. Yeah what would it be. And then you can and then you can talk about ask a series and actually you could talk about what's the response you put here?

OK Yeah. So I'm going to phrase this like if you had one piece of advice she gives Winston cruise, Crowe is looking. Looking to implement some of the ideas we've discussed today or something? Yeah yeah, that sounds good.

Cool so if you had one piece of advice you could give to sponsors and CEOs who are looking to implement some of the tools and technology we've discussed today, what would it be? Starting with you, Maria. I would definitely say ask your theories, because your theories have already tried different tools, especially if they're experienced. They've seen they haven't seen it all, but they've seen different, let's say, types of tools and different tools within the same categories.

So ask them, ask what would it make what would it make it better for them? What what would make their life easier? So they will tell you they have a voice, just hear them right. And then if you provide them with a tool that will suit their needs, their pains and their challenges will be just covered and fulfilled.

So what better than having a happy theory? Who knows that there are supported by their they are over by their sponsor and they know that whenever they have a difficulty, they can come in and say, this is my difficulty, this is what I would need. And you get your support from your study team. Agree and coming off of

what Maria's response was, I believe it's a two pronged approach, meaning internally, as she has stated, speaking with your series, being clear and open and giving them that open space to give you the advice, to give them the advice.

But also, I'm obviously I'm biased, right? As one of the co-founders of the University of clinical research. I do feel that zero's and sponsors are looking to increase their candidates and have made efforts in those strides to provide entry, you know, as a stepping stones for those with no experience. However, you know, entry numbers and/or rates, retention numbers, right.

Are still not that large and they can't guarantee that everyone stays and/or makes it through into roles. And so I think it's very important for the external individuals that have yet to make it through the process. Right to work closely with organizations that are prepping and/or tailoring incoming students and their learning styles. Right because ultimately.

Right if you're trying to bring somebody in, Yes. You get a great candidate. But you need to ensure that they complete onboarding and that they maintain afterwards. Right so if you're still also currently working on communication internally, it's very hard to do both at the same time.

So you need to work with organizations that are already focusing on that so that you can say, hey, this is what we need. Can you simplify that process for us. So that it kind of get not guarantees but at least heightens the percentage of the passing rate for these individuals, right? So that there's quicker understanding, there's quicker pick up, you know, there's less burnout and there's better communication.

Right as far as what they're coming into. And I think that that's where the minute miscommunication is. And so definitely working with organizations and tailoring the new incoming employment to fit their needs specifically. Right so.

great. Ashley and Maria, Thank you so much for your amazing contribution on this topic. You've both given us food for thought, a workable solutions to address this with ideas that could potentially be adopted industry wide. Again, I put the final message here.

So I don't know if I need to put a final message here. Final message is in, you know, just to end the series. Yeah I mean, I don't. Yeah hold on, ashima.

They didn't leave like a closing statement on my end. I didn't know if. Yeah, you did. Yeah I mean, I think we've kind of touched on these.

I think this would just be going over old ground. OK do you think we'll need to sustain benghazi? Yeah, I think I mean, you've just given your final messages, so I think. Yeah so I'd say, Ashley Marie, Thank you so much for your amazing contribution on this topic.

You've both given us food for thought on workable solutions to address this with ideas that could be potentially adopted industry wide. So Thank you so much and I hope you'll come back on the podcast sometime soon. And then we'll end it there and I will stop calling it in.