Clinical Research Has a Workforce Shortage. Here’s How to Solve It - Judy Galindo, Monica Cuitiva

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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: It is not overstating it to say that clinical research has a workforce

issue. This is a problem because every one of us benefits from the hard work of staff at all levels of the industry. Now the reasons for the workforce shortage are multifaceted, and here today to discuss more about this topic are Judy Galindo and Monica Cuitiva, co-founders of Latinos in Clinical Research, an organization to help increase Latino participation within the research community.

Hello, Judy and Monica and welcome to the podcast. Now, let's start by examining exactly why there is an issue of workforce shortage in the

industry, starting with you, Judy.

JUDY GALINDO: There's various issues that are contributing to this. One of the things that a lot of people don't know about the clinical research industry, so they don't know, there's so many different job opportunities or those who might have heard about it don't really know how to get started to get into the industry and learn about it. And then those that are in the industry that maybe don't have a lot of experience have trouble advancing or going on to other positions because the lack of training.

So clinical research has been around for a very long time. I think, in general, people don't really understand what it is compared to someone who's a doctor or a vet, and I think that's why we have a shortage in the industry. But if we have more opportunities out there to get more people into the industry in the various communities, we would have a lot more people that we can put into various positions, whether at the site level, at the sponsor, CRO or vendor level.

HANNAH LIPPITT: And Monica, what are your thoughts?

MONICA CUITIVA: It's also known that the research industry – or what we do in research – is not a popular topic. I mean, nowadays with COVID, it became a little more popular. But we need to educate people about the clinical research industry and what it is to be part of this. Sometimes people are scared of jumping on a different industry, especially this one that seems to be only for people with white coats, right? So that's another factor that could be affecting. So we

need to start educating the younger population about it so that way we can break that stigmatization about this industry and obviously giving the opportunities to those that are entering industry as a new entry-level positions. In that area, we need to expand, especially the sponsors and the CROs, to give opportunities for people to do entry level positions, because the majority of this get through the clinics, the clinics train them and then the sponsors get them, unfortunately because of the shortage in the industry.

HANNAH LIPPITT: I know that there's also a problem of retention. Once people have been recruited,

they don't always stay for very long. Why is this and how can we resolve this? Starting with you, Monica.

MONICA CUITIVA: OK, so I was mentioning before that the reason why is obviously because of the shortage. So the sites train, oftentimes this new entry-level positions, and then, and then they get opportunities or they see opportunities to go higher, which is normal, right, within the industry. However, if the whole industry, they get the CROs, the sponsors and the sites give opportunities to these entry levels, it will naturally bring, obviously, more professionals, but then at the same time, it will bring diversity as nowadays due to COVID, people have a little bit more knowledge about what is research. And I think this is the great opportunity for us to educate

more about it. This will help also the industry shortage and therefore also the retention.

HANNAH LIPPITT: And Judy, Monica talked about how the companies need to give opportunities to entry level people who don't necessarily have much experience. How do you think that this can be achieved? Because a lot of companies, they demand experience.

JUDY GALINDO: Being a site owner for a small research center, I think there's a lot of things different companies can do. Opportunities such as offering maybe internships, entry level training opportunities where somebody can get started at your site and from there you can see what their strengths are and maybe what you can transition them into. So, having those resources available could help with hiring and retaining staff, what opportunities do you have that you're going to offer at your company to get in and to be able to advance? Because that's what people are looking for. They want to get in the industry. They want to work in this field and they want to move up into and find that position that works best for them.

So, we have to be able to offer those opportunities, but we need to have these available at

various time points, I guess, when you enter clinical research. So not everybody has that experience as Monica mentioned and we were talking about. So, what are we going to do to change that, to get those people in and what can we offer at our sites, at the sponsor, vendor, CRO levels to get these people in?

MONICA CUITIVA: And Judy, I would like to mention also that

sometimes you see that they post jobs that they say “entry level”, but they require one year experience, so that's not a true entry-level position. What we really need is true entry level positions.

HANNAH LIPPITT: Sponsors and CROs definitely play a role in resolving this problem. Judy, I know you have some thoughts about resources.

JUDY GALINDO: I think a lot of the protocols that we are working on that we get at the site level have become more challenging in regards to the criteria, inclusion criteria, exclusion criteria, the type of participants we're looking for and what we're collecting in the study and in the protocol, a lot of different electronic systems, different vendors, portals or diaries that we're using. And so sometimes I feel as a site that the sponsor CROs give us the study, they give us all these things that we need to use and they don't really provide much support, training, additional resources to help sites like ours recruit, manage the day-to-day aspects of the study, use the various systems so it becomes challenging. And so it pretty much falls on the sites and the site staff to figure this out, to make sure they have the staff that are trained on how to use everything that we need to use, all the protocols and we have to get additional staff sometimes to support specific protocols, and sometimes we have five or six people working

on one protocol alone when we have various other protocols going on at the same time.

So as a site owner, site representative, I've actually reached out to sponsors and CROs and have asked them, “What support can you provide us? Because we need help, we need assistance.” And some have been very responsive and have provided additional resources, others haven't. So I think we just need to change the way studies are designed a little bit easier and support sites more on these studies.

HANNAH LIPPITT: And Monica, I know that you also have some thoughts about training as well.

MONICA CUITIVA: Sometimes the sponsors forget about or actually don't really know how the sites work and I think that's why people took part that they need to get this communication, this true understanding of how the sites work. Because oftentimes, let's say in one study, the staff members could involve doctors, nurses or other type of clinicians. And this could become costly for the site to train all these people because nobody is going to work for free, right? Unless you're part of a company that does that. But for example, sometimes when the clinicians come for training and then the sponsor oftentimes just pays very little for this kind of training, so the sites take into their finance this part, right? And then the sponsors need to be more in touch with the sites, so that way they can understand the level of work that takes place in the sites.

At the end of the day, the site is the one that do the hard work, the ones that go to the field, get the patients, do all

the testing and complete the protocol, right? So, it is important that the sponsors understand all this process and the difficulty oftentimes that is involved in all of this so that way they could do a better work. And I think that could be obviously reflected in better studies, in more diverse studies, also, because the sponsors also sometimes make it difficult for the sites to get this diverse group that is needed in every study. So the support definitely needs to be bigger for the sites.

HANNAH LIPPITT: Are you optimistic that this will happen?

MONICA CUITIVA: I am. I think it will happen and it will happen whether the sponsors work right now on it or not, because the statistics show that the population is going to be

highly diverse. Just United States overall and then on top of that, the new professionals come in, which are the new generations are looking for companies that have more meaning, for companies that work more towards these kind of goals, that involve more diverse, that works for everybody.

JUDY GALINDO: Yeah and as a site owner working at a site level, I have seen this with some sponsors who have invested, you know, their time, money, effort to support sites and to make this happen. So I am optimistic it's going to happen. It is a slow process, but it does involve a lot of players in order to make a difference.

HANNAH LIPPITT: Yeah, change does take quite a while in the industry due to its conservative nature. Now, moving on to awareness raising: what other kinds of solutions

are out there to help people learn more about the industry? Monica.

MONICA CUITIVA: There are a lot of trainings out there. And for Latinos in Clinical Research, that's part of our mission, right, to educate people. So, what we're doing is we're educating people in different levels. Like, for example, for people that want to know overall about the industry, we have webinars monthly, then we also offer classes, and this we do it through the University of Clinical Research in which we have different classes for different areas. This is starting from the grassroots, like for example, the clinical research assistant and then going to the clinical research coordinator, the clinical research associate,

then for clinicians, for medical writers, for data management. So, we're trying to educate in different levels for people that are just entering the industry and want to have a solid foundation to start a new career or for people that are already in the industry that want to advance into a different position.

HANNAH LIPPITT: And Judy, from the site owner

perspective, do you have any thoughts about the training options available?

JUDY GALINDO: So, I'm excited. You know, everything that Monica described helps me

as a site owner, bring on new people to start with this, because I can use all those different resources that we have to get my staff trained and then it's less time internally that we have to spend on training them because these didn't exist, these are recent, the past several years, but I've been in the industry for 18 years and we didn't have all this training 18 years ago.

So, it is challenging bringing on new people to say who don't have any research experience. And internally a lot of us have to create these trainings that we have that are specific to our sites. But I always like to supplement those internal trainings with other trainings that exist in the industry that can bring on this person faster to start with.

HANNAH LIPPITT: And going back to the topic of hiring people who are new to the industry, how has this gone for you?

JUDY GALINDO: In my community, when I hire people, there's nobody with clinical research background. So I do take a chance on new recruits. I hire people with a psychology background, medical system background, phlebotomy background – at least they have that part of it – and it's easier to train on the clinical research aspects. So, most of everyone who got started with us at our research center didn't know anything, and they were trained internally and have been with us several years. I have a lot of new people that started recently and this is the process we have gone through. So, like I had mentioned, I'm excited that these academies and different trainings exist now because it makes my job easier and I think a lot of other research centers and other companies should take a chance like that and bring on people. And it is a grassroot effort. You actually have to sit with them and, you know, go from the beginning: “What is clinical research?” It's a lot of work, but once you go and you train that person, a lot of these people are very dedicated and will stay with you for several years.

HANNAH LIPPITT: As a site owner what types of training do you feel are most effective?

JUDY GALINDO: Online trainings are excellent, but also exposure, hands-on exposure, shadowing coordinators, research assistants, various other positions within, that's the training that's required to bring these people on – it's a combination of both. And I think sometimes we forget, because we're so, you know, the past couple of years, everything's been online, electronic, remote, but that person-to-person, as we had mentioned, grassroots effort, that's part of the grassroots effort of actually having them come into your site and do internships, you know, offering, opening your site to bring on these students who have completed this programs and actually giving them the opportunity to have a hands-on learning experience.

HANNAH LIPPITT: Could you explain more about what specific issues face the Latino community when it comes to clinical research, recruitment and knowledge? Monica.

MONICA CUITIVA: In

our community, in the Hispanic community or Latino community, I think that the biggest challenge is that we don't have much material or is also lack of awareness about clinical research. And this is obviously doesn't give people the comfort to be part because they still scared of the industry or they still scared of pharmaceutical. It is important to educate them, it is important to inform. It is also important that the sponsors, the CROs and the sites work together, creating material that educate this population.

I think on this site level we do a lot of work about it,

but we need to sponsor and the CROs to support in that area. Even the FDA now has the guidelines for diversity and have more requirements and is pushing the diversity part. Oftentimes you see studies in which you are not given material in different language rather than English. So that makes it more difficult for sites

to reach out to these specific communities. Like, for example, in our cases like Judy and the sites, our sites are located in a high population of Latino communities, we have that difficulty because the material is not really available, and obviously there are no match sites or a lot of professionals like doctors or clinicians that speak the language at the same time. So the education part is really, really important.

JUDY GALINDO: The lack of awareness, lack of materials, that's a huge barrier. It puts us behind on recruitment if we can't recruit Spanish speakers. And sometimes occurs and months and months later, we get the Spanish material. But the other issue in my community – it's about 80% Latinos – is the lack of education of clinicians who don't know about research. They never worked in it. They never participated. So they don't talk about clinical research studies to their patients. And so this is where we need the sponsor, CROs, vendors – everybody else in the industry – to assist sites in these communities, to educate these doctors, to let them know that there's clinical research studies going on in the community. We're doing it at the site level, but we need more support for that.

HANNAH LIPPITT: Looking to the future, how do you see the industry shaping up when it comes to addressing the issue of workforce shortages over the next few years? Monica.

MONICA CUITIVA: I have seen many organizations that right now are doing some trainings and trying to bring more of this diverse group of professionals. However, I think we all need to walk the talk because the majority of organizations are talking about this, but very few of them are really doing it. I see the company is doing it like Judy was saying it before. I see the companies doing it slowly – they will get there – but at this point where we are and we need the industry to move faster and this is also to be reflected in the products that we're bringing to the ward, right? Like, the new treatments and the new generation of drugs and equipment. So, I see a bright outlook, I see good opportunities out there. But again, the companies and we all at the same time need to walk the talk.

HANNAH LIPPITT: And Judy?

JUDY GALINDO: I do see a lot of positive change happening already. There's been a lot of discussion the past couple of years. There's a lot of organizations that are doing great things already. And I think collaborating is one of the things that maybe we need to do more of in this industry. I don't see a lot of that happening. Everyone's kind of doing their own thing, but maybe if there's a way we can come together and how can we work with each other to address the issues we have in this workforce to improve it. But I do see some change already happening, and it's going to take all of us to change this, to address these issues, not just one organization, not just one company or one site, but I think if we're all aware of that and we each contribute and do something to change this, we'll see a significant impact on the workforce and more people entering it who have never heard about clinical research hopefully in the next several years.

HANNAH LIPPITT: Well said, we all need to work together to improve the situation. Thank you so much to both of you for taking part in the Totally Clinical podcast. Now, to learn more about Monica and Judy’s work, listeners can visit LatinosInClinicalResearch.com and UniversityOfMedicalResearch.com. You can also connect with Monica Cuitiva and Julie Galindo on LinkedIn if you’d like to reach out directly.

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!