THE CLINICAL RESEARCH WORKFORCE

 

Trial Better host and ERT’s Director of Operational Readiness, Jason Eger, is joined by Jim Kremidas, Executive Director of the Association of Clinical Research Professionals. They explore the current state of the clinical research workforce, why sponsors should be concerned, and changes the industry can make to improve and expand opportunities for clinical research careers.

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episode notes:

 

Jim, tell us a little bit about yourself and your work at ACRP.

I started my career at Eli Lilly for 24 years before moving to Quintiles, now known as IQVIA, for 5 years. After spending the following five years consulting, I became the executive director for ACRP.

What is SCRS and its mission?

The SCRS was founded by Christine Pierre, who passed away two years ago. However, SCRS’s drive and motivation is based on Christine’s vision of what’s missing in the clinical research space. She believed that sites should have a seat at the table in the clinical research community. In the past, sites were seen as somewhat of a silent partner. The SCRS was developed to raise the voice of sites, and we’ve done that – we now represent over 10,000 sites in more than 50 countries across the world.

ACRP recently released some data on the state of the clinical trial workforce. I want to dive into what that data revealed. What trends are you seeing in clinical research career opportunities right now?

Recent trends in clinical research career opportunities include a disproportionate growth rate of clinical studies compared to the size of the workforce. We believe strongly that we need to close this gap to get therapies to market as quickly as possible.

What might a typical career path look like for someone entering the clinical research industry? Do you need to have a scientific background to be successful in clinical research?

Right now, I am not sure there is a typical career path. Most people who end up in clinical research typically come into their positions by chance. That lack of clarity in career entrance and development is a huge problem.

In previous episodes, we’ve heard about the importance of recruiting diverse patients for clinical research. Can you speak on the importance of having a diverse workforce in clinical research as well?

We feel like we can kill two birds with one stone so to speak. Growing the diversity of the workforce can in turn grow the diversity of those enrolled in clinical trials.

WWhat are the potential consequences of clinical trial growth outpacing clinical trial employment?

A potential consequence of the outpace in growth between clinical studies and the workforce in clinical studies is that we won’t have enough people to conduct studies to the extent that we need them to. This will be a bottleneck in the development pipeline.

What can sites, sponsors or CROs do to encourage interest in joining the clinical research industry?

The more variance you have, the more likely you are to have poor quality, and unfortunately that’s the case in clinical research now. It’s critical that we begin defining competencies for positions in our industry. When we gain industry alignment around these competencies, we can begin to train individuals on them, and then validate that people actually have them. This is the only area in healthcare where there are no real standardized requirements or competencies. We need to change that.


Transcript:

Jim Kremidas (00:02):

There’s just no clear path into clinical research and that’s a huge problem. So one of the opportunities that we see is raising awareness of clinical research as a career option.

Speaker 1 (00:15):

Welcome back to The Trial Better Podcast. Today our host, Jason Eger is joined by Jim Kremidas, Executive Director of the Association of Clinical Research Professionals. Jim will share the latest on trends in the clinical research workforce. He’ll reveal what the numbers tell us about changes the industry must make to meet demand for treatments that not only cure disease, but improve the patient’s quality of life. Listen now, as we learn more from Jim on Trial Better.

Jason Eger (00:44):

Hi everybody and back to the Trial Better Podcast. I’m your host, Jason Eger and today I’m excited to be joined by Jim Kremidas. He’s the Executive Director of the Association of Clinical Research Professionals, or ACRP as we’ll refer to it. We’re excited to have a great discussion on a clinical trial workforce. Jim, welcome to the Trial Better Podcast.

Jim Kremidas (01:04):

Hi Jason. Thanks for having me. I’m looking forward to this.

Jason Eger (01:07):

We are too, and thanks for being here. So, but why don’t you start off and just tell us a little bit about yourself and your work at ACRP?

Jim Kremidas (01:14):

Sure. Well, I actually started my career at Eli Lilly and was there for about 24 years in a variety of roles. And then I left and went to a very large CRO, Quintiles at the time, now known as IQVIA. Worked at another CRO for a while. I was actually at IQVIA for about five years and then did some consulting. And about five years ago, in fact, just slightly over five years ago, I started with ACRP as the executive director. I’m really excited about working with ACRP because our mission is really to drive better quality in clinical research. And we’re a not-for-profit. The organization was founded in 1976. We have about 13,000 members, but we also do certification programs and that’s another 13,000 people, about 60% of those overlap. So our overall reach is somewhere around, I don’t know, 18, 17, 18,000 folks that we can communicate with on a regular basis. And we also have a number of folks that we work with who are not members, but we distribute information to them. And our reach is around 60,000 people in the clinical research space for updates and communications and things.

Jim Kremidas (02:32):

So it’s really exciting for me to be part of this because we all know that clinical research really is an area that needs some work. And what I mean by that is it typically takes us so long to bring new therapeutics to market, whether they be devices, drugs, whatever, even just data that doctors can use for making good clinical decisions. And so what’s been happening in the industry because of such an acute awareness of this over the last 10 years or so has been a plethora of new technology developments. I don’t even have to go through all the list. There’s so many different technology providers these days that are coming up with great ideas on how to make clinical studies, or clinical research, more efficient. And then at the same time, we have a number of process improvement initiatives taking place like TransCelerate, the Clinical Trial Transformation Initiative, the Avoca Group, each company it seems in pharma has their own process improvement initiatives going on.

Jim Kremidas (03:33):

So that’s all good, right? But when you talk about change management, there’s a third leg to the stool. It starts with tools. So, technology and data. It also includes processes, but the third leg of the stool is people. And so that’s the area where we are focused. We’re all about how can we help enhance the quality of the workforce and help people do a good job as clinical researchers. So that’s where we really feel like we fit into the change management processes that are going on today.

Jason Eger (04:08):

No, I think it’s a great way of looking at it. And I know recently ACRP released some data on the state of a clinical trial workforce, and I know that you were touching upon it there, but why don’t we go into that a little bit deeper? What trends are you seeing in clinical research career opportunities?

Jim Kremidas (04:28):

Well, so it is a great question. We did a study to look and see what is the volume of work, and do we have a workforce that has enough capacity to really deliver the data and the studies that the environment requires. The bottom line is clinical studies are growing at a rate of about 12% per year, but the workforce is only growing at about 9%. So there’s a 3% gap between how much work needs to be done and how many people there are to do it. We believe strongly we have got to fill that gap because patients are waiting, we’ve got to get these therapies to market as quickly as possible.

Jason Eger (05:10):

So there’s a lot of individuals out there that are looking for a career for themselves. And for those of us that have been in clinical trials for so long, we love what we do, and we love the morality that it helps people and helps patients. So with that, Jim, why don’t you talk a little bit about, what does a typical career path for someone entering clinical research look like?

Jim Kremidas (05:36):

Well, Jason, that is a great question, because right now I’m not sure there is a typical career path. And it’s really interesting when you talk to people about how they got into clinical research in the first place, it’s almost always some type of serendipitous answer. I knew a guy who knew a guy, or, one of my favorites was, I was the receptionist in the doctor’s office, the coordinator quit so suddenly I became the coordinator. So there’s just no clear path into clinical research and that’s a huge problem. So one of the opportunities that we see is raising awareness of clinical research as a career option. Almost everybody I talked to who is in clinical research, fell into it. They didn’t go to college thinking I’m going to be a clinical researcher when I graduate.

Jim Kremidas (06:27):

So what we’ve been doing is working with a number of different organizations, and I’ll come to this in a minute, but it’s called the Partners in Workforce Advancement. And one of the objectives of this group is to raise awareness of clinical research as a career. And we’re doing an online media campaign with high school juniors and seniors and people in college. And the idea is to, again, to help them think about clinical research, as a possibility of where they’re going to pursue a career. And to your point, I have to tell you, one of the things I love talking about clinical research is this is the ultimate pay it forward business. I mean, everything our members are doing today, pays benefits down the road for our children, our children’s children, et cetera. So it’s really an exciting career.

Jason Eger (07:23):

I completely agree. And I’m laughing at myself here, Jim, I will just let you know, my first degree was hotel restaurant management. And just as you said, a lot of us just fall into it. And I’m thankful that I did. So with that, we also talked in a previous episode about patient diversity in clinical trials, and making sure that we are reaching out to all demographics. Do you have some thoughts on diversity in the clinical trial workforce?

Jim Kremidas (07:55):

Absolutely. Yeah. In fact, that’s a great question, Jason, because we feel like we can kill two birds with one stone so to speak. On one hand, we know we need to grow the workforce, but at the same time, we also know we need to grow the diversity of the workforce. Why? Well, we all know that there’s not enough folks of different cultures and underrepresented populations that are enrolled as patients or volunteers in studies. Well, there’s been a lot of work done on how to communicate effectively with these folks and build trust, et cetera. But what’s the quickest way to do it? Having people talk to folks from the same background as themselves.

Jim Kremidas (08:39):

So if we believe that if we can grow the diversity of the workforce, that will in turn, grow the diversity of the populations volunteering for these studies, because there’ll be more trust, better communication, et cetera. So as we are doing these campaigns that I mentioned earlier from the PWA, by the way, it’s called Find Your Element. That’s the name of the advertising campaign. We’re targeting minority populations so that hopefully we can get these students again, thinking about clinical research as a career and bring them in.

Jason Eger (09:12):

So I think the number you said that the clinical trials are growing at 12%, but employment in clinical trials only growing at 9%. Is that what you said?

Jim Kremidas (09:24):

Yeah.

Jason Eger (09:26):

So why don’t we talk, what are some of the potential consequences of this?

Jim Kremidas (09:31):

Well, I think the most obvious one is the fact that we won’t have enough people to conduct studies to the extent we need to. In other words, it’s a supply and demand issue. If we don’t have the capacity and the workforce, we’re not going to be able to get all the studies done that we need to get done, to get new therapeutics out to patients. So it’s really a downstream impact. It’s interesting, my entire career, I’ve heard people talk about, we don’t have enough investigators. Most recently there’s been all kinds of information about we don’t have enough site monitors and there’s been this competition to hire CRAs across the CROs. If we had more people in the business, we wouldn’t be having those problems.

Jim Kremidas (10:19):

And by the way, the same is true with study coordinators. One of the complaints we hear from investigator sites is, hey, I get this study coordinator trained, and then they get hired as a CRA and I lose them. We need to have succession planning structured too. And back to your earlier question, there should be a career path where, and I’ll go, even before you start your career, you become aware of clinical research as a career option. You can get information on how to study to be a clinical researcher. There are universities now offering this as a curriculum. You can go to a place like ACRP and download information and learn the fundamentals.

Jim Kremidas (10:56):

There are other organizations too, that do a lot of training. So you get trained. Hopefully, as you’re in your training process, you get an internship somewhere so that you can get some hands-on experience and some mentoring. Hopefully then you wind up working in an investigator site, perhaps, and then you spend time there and you learn what it’s like to be a study coordinator. You advance as a study coordinator, and maybe eventually you then transition over to a CRA position. You work your way through the CRA ranks. Maybe you become a project manager. Maybe you go down a different direction, overseeing multiple trials. Those are not uncommon ideas, but again, there is no real standard methodology or path in today’s environment. Does that make sense?

Jason Eger (11:45):

Yeah, it makes complete sense. I mean, and if you look at clinical trials, there are so many different ways to be involved. Whether it be any of the stakeholders you talked about, site coordinators, CRAs, but like you said, there’s vendors, there are vendors, there’s technology, there are tools. So there are a bunch of us in the industry. And so many of us have made our living in this, in clinical trials. So I’m very appreciative that the work that you’re doing to encourage the growth of it.

Jim Kremidas (12:13):

Can I point something else out that I think the industry really needs to be aware of?

Jason Eger (12:17):

Please.

Jim Kremidas (12:18):

If you’re involved in any type of process improvement initiative and I’ll use Six Sigma as an example, one of the first things they tell you is the more variance you have, the more likely you are to have poor quality. Okay. So think about our industry and back to the earlier point, how people come in and how they’re trained. You want to talk about variance. I mean, there literally is no standard in today’s environment. So one of the things that, one of the other things that the PWA’s been working on is defining the competencies at the role level. What are the competencies a coordinator needs to have? What are the competencies a PI needs to have, or a site monitor? Okay.

Jim Kremidas (13:01):

And we want to get industry alignment around those. And then of course, trained to those competencies and then validate that people actually have those competencies. That’s something I feel is a huge paradigm shift in terms of how we think about the workforce. But it’s absolutely critical that we achieve that. This is the only area in healthcare, where there are literally no requirements to have certain roles. I mean, literally anybody could be a CRC, anybody, you don’t even have to have a college education. So, I mean, not that that’s necessarily a requirement, but still we need to decide what exactly is the requirement for those roles.

Jason Eger (13:42):

And are you getting buy-in from sponsors and CROs with the PWA initiative?

Jim Kremidas (13:48):

Yes. Now it’s slow but sure. We have defined the competencies over the past couple of years for coordinators, PIs, monitors, and we’re going back and doing monitors over again because of the changes that are taking place in those roles. But our PWA consists of, we’ve got some very large academic institutions in terms of that type of site. We have the FDA, we have NIH, we have SCRS. So they represent more independent sites. We have CISCRP representing the patient perspective. Merck is on board. Genentech, Roche is on board. We’ve got a very large CRO that’s about to sign up. And then we’ve got all types of other technology companies at the lower tiers. But the strategic planning tier, what we call our Executive Steering Council, those are the folks I just mentioned. They’re giving us really great insights into how we move this forward and how we gain industry alignment around these concepts.

Jason Eger (14:58):

And that’s really encouraging. I mean, it sounds like you’ve made great progress. I know it might feel slow, but that’s a lot of groups that are starting to get involved and hopefully with a broad reach.

Jim Kremidas (15:08):

Yeah. We’re excited. You know, I mean, by the way, I should also mention all of these things that we’ve developed are available for free, which is another reason we feel like we can get industry alignment eventually. So anybody that wants to go in and download those competencies, they’re on our website.

Jason Eger (15:26):

What is the website for people that are listening?

Jim Kremidas (15:29):

It’s Acrpnet.org. Acrpnet.org.

Jason Eger (15:35):

All right. So Jim, unfortunately, I mean, I think we can talk about this all day. I’ve really, I mean, thank you for shedding light on this for us, but are there any other final thoughts that you want to share?

Jim Kremidas (15:48):

Well, you know what, well, first of all, I want to thank you for having me. And as I mentioned, we have a real opportunity in this industry to enhance the quality of the workforce especially if we work together and align ourselves around what are the competency requirements, how do we train to those, get industry alignment around those? And then how do we validate those through certification? And if we’re able to do that, we will make a quantum leap in the quality and the speed of the data that we’re able to provide to healthcare professionals.

Jason Eger (16:27):

Great. Jim, thanks so much for joining us today on Trial Better Podcast. You really offered some great knowledge and thanks for the work that you do on ACRP on really how we make clinical trials run more smooth every day. So to our listeners, thanks as always for tuning in, feel free to share any feedback with us at trialbetter@ert.com. And please don’t forget to like, and subscribe to Trial Better on your favorite podcast platform. We’ll see you all next time on Trial Better.

Speaker 1 (16:54):

Thanks for tuning into this year’s final episode of Trial Better. We appreciate Jim stopping by to break breakdown how the clinical research industry can improve and expand the workforce that is critical to the success of any study. Please remember to comment, rate or review Trial Better on Apple Podcasts or your favorite podcast channel and subscribe now at trialbetter.com to make sure you hear from us when we returned with new content in 2021. In the meantime, you can always reach us at trialbetter@ert.com. Thanks for listening.


FEATURED GUEST:


Jim Kremidas

Jim Kremidas, Executive Director, the Association of Clinical Research Professionals

Jim Kremidas is Executive Director of ACRP, a non-profit association representing the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors, and suppliers. He was SVP of Patient Recruitment at two different large CROs for 6+ years where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company, leading their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms, and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Kremidas led Lilly’s efforts to select and establish relationships with direct-to-consumer and professional advertising agencies, as well as, implement standardized processes for the development and implementation of marketing materials.


ADDITIONAL RESOURCES:


Visit the ACRP website

View the Special Report: An Assessment of the Adequacy of the Clinical Research Workforce

Learn more about ACRP Partners in Workforce Advancement

Learn more about Find Your Element

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