Episode 21: Laura Holtz, Regenstrief Institute
Laura R. Holtz, MS, PMP, CCRP, is a Senior Research Manager at Indiana University Center for Aging Research and Regenstrief (re- gan- streef) Institute. She oversees multiple federally funded grants and investigator initiated research trials includes projects with cognitively impaired older adults in the community and nursing facility settings. As a research staff advocate, Laura established the Indianapolis chapter of SOCRA, the Society of Clinical Research Associates, which provides education opportunities for staff to become Certified Clinical Research Professionals. She has presented several times at the SOCRA annual conference and SOCRA chapter meetings. Her dedication to research education earned her seat on the SOCRA Board of Directors in 2018 to present.
In this episode, we discuss the continued emphasis on being a generalist, the idea of clinical research as customer service and the importance of authenticity in communication.
+Full Episode Transcript
Brad: All right. Laura Holtz. Thank you so much for coming on today.
Laura: Well, thank you for having me. I'm very excited about this.
Brad: Yeah. So we had to reschedule due to the weather. I apologize for that. We did. We talked about that. Unfortunately, I can't control the weather, even though I've tried,
Laura: As we all try to do at our sites, we try to control everything.
Brad: Yeah, Right? For better or worse sometimes. So as always, I like to start out with, uh, you know, I like to hear about people's origin stories. So, uh, tell me a little bit about how you got into clinical research and kind of up until where you are now,
Laura: But yeah. So my story is kind of like everybody else's, I didn't know about this profession and fell into it. I think we hear that quite often, but mine's a little bit more convoluted than that. So, um, I actually trained to be an-a high school English and speech communications teacher taught for a couple of years. Wasn't quite the right fit. And I started kind of thinking about what other options I had took some twists and turns and some jobs along the way, and kind of through my experiences, I had heard a presentation by one of the investigators at Regenstrief Institute, and that's where I currently am employed. And I've been working my whole research career at Regenstrief. And so I heard presentation about how to use electronic medical records and data for research. And it was a very entry-level presentation, but it was really inspired and intrigued. And so then I started looking into the organization and the company. And just to kind of give you a little bit of background Regenstrief, it's a nonprofit research institution. It's looking at research and supporting the research of Indiana University and they have research in biomedical informatics and health services research in aging. And so when I started looking into the organization, I was pretty intrigued and they had a job posted for a research coordinator. And I was like, well, I'm a been a project manager for a couple years and I know how to manage projects. Oh, how hard and different can it be? And so I very naively threw my hat into the ring for that position. And then once I got into it, I really found that I really enjoy and love the innovation and the investigation of research. Um, I, it really serves my project management mind to set up things in processes and with SOP is, and we joke that I love SOPs. So it was, it was one of those things that not everybody loves SOP's, but they really work well for me. And it matches really well with my training as a teacher to have, uh, metrics and to have rubrics and to understand how you do things in a logical way to get to an answer of some question of some sort. So working in research, really combined a lot of the things that I really enjoy those things about teaching and learning and having, you know, very systematic processes to get to an answer and finding new knowledge and investigating these hard questions and getting the answers. And I really was drawn to that. And so I started as a entry-level research coordinator and, um, learned the ropes from those who were working, uh, in the center for aging and continue to kind of grow my skillset from there. And I've been working at Regenstrief for now more than 13 years. And I'm at that level of the senior research manager, which, you know, title wise really means that I'm working for multiple investigators on investigator initiated trials and staffing those trials and ensuring that they're successful, that we can, you know, from that grant inception to closing out studies and publishing on our results. So just kind of worked my way through the ranks to understand the research as a profession, and then also, you know, where my fit was within it.
Brad: Sure. And I, you know, again, that's I say again and again, I think this is part of the beauty of clinical research. I think there's really whatever your interest is. There's a little piece of it somewhere in clinical research. Uh, and then it really comes down to, you know, how, how much can you hone in on that? Or how much can you sort of expand out from that? But again, what's so great about it is that I think whatever your interest is or interests are, or even where your values are, that it's somewhere, it's somewhere in there in clinical research. If, you know, if you know where to look,
Laura: Oh, there are opportunities for anybody in this profession. You know, I've got a data manager who just is fascinated by the data and I can't get my head wrapped around it, it doesn't, can't figure out what she loves about it, but she and I work really well together and have worked well together for a long time because we compliment each other so well, if it's a data question I'm going to go to her. If, if it's a procedural question, we typically will look at my expertise or my area of interest. And so really finding your colleagues and your cohorts that work well together really makes the, the research exciting. It makes that teamwork, that dynamic work environment, fun, everybody gets to have a strength. And I think that that's important.
Brad: Yeah, it's true. I mean, I know, I think it's important to have a full understanding of the breadth and depth of clinical research and to be very well-rounded, but I mean, let's be honest. We're not all good at everything. I mean, we're, we're just not, you know, I'm, I-I'll-I'll say publicly, I'm not a very good research coordinator. Uh, as far as that particular aspect of the job, when it comes to very detailed, uh, data collection, it's not the way my mind works. I don't, I don't like it. I mean, it can do it. I'm just, I don't like it. So just like you said, if you can find those strengths and then put together a team that compliments each other, I mean, there's a, obviously a ridiculous amount of in that. And I don't know that that's always appreciated, uh, when, you know, sometimes a lot of sites ask their, their coordinators or managers to do everything.
Laura: Yeah. The generalist is important. I mean, it's important that we know how all the pieces fit together, but finding that passion of those specialty areas that you personally thrive in, I think is important, you know? Yeah. We can all kind of do the regulations and we can meet those specifications that we have to, and we know those things, but it's the, that where you get excited about the research, where you get excited about something that you're contributing to this, this large process, because clinical trials is such a long and lengthy process that where you can get excited about your piece in that long process, it is rewarding. It is valued and valuable. So yeah, it it's, it's fascinating. Um, yeah, I, I know, I don't know very many people who get super excited about those SLPs and making sure everybody, you know, knows how to do things, but it just it's how my brain works. And being able to optimize that and being able to help people to, you know, cut out the waste in their jobs and not have to do the things that maybe aren't meaningful, if they don't aren't necessary. Like let's figure that out. Let's optimize that. I think that that's a cool, cool innovation, uh, in something that's kind of prescribed in clinical trials.
Brad: Yeah, it is. And again, that's, I mean, it's awesome that you've been able to find that that fit for yourself. I know there's a lot of people still, still looking for it within their career. So that's really awesome. So tell me a little bit about Regenstrief. So you guys do mostly sounds like an investigator initiated trials, or other than your sorta more run of the mill drug and device studies.
Laura: Yeah. Yeah. So, so they do have some drug and device trials that, that different folks are running. You know, Regenstrief really, it was founded as an Institute by same Regenstrief who actually is a manufacturing person and saw that there was a need for manufacturing in healthcare. And so even in our office foyer, we have a dishwasher because that's what Sam Regenstrief. manufactured was dishwashers. So we really think about the process of health care and thinking about how to make innovative strategies to do it better. So not doing drug and device trials kind of makes sense when, you know, our origin story, you know, we're looking at healthcare delivery, we're looking at implementation science, we're looking at, you know, translational science. So taking those best practices that we know work that no work in the clinical setting and being able to put them into the healthcare setting. So I've worked about the last eight years on a project that was funded by centers for Medicare and Medicaid services, where we were trying to take best practices into the nursing home environment. And, you know, we had the program was called "Optimistic" because that's what we felt about it. We felt it was interestingly an acronym, but I can't always remember what it stands for, but the purpose of the acronym was to be, to have a feeling is that we felt optimistic that we could do this in a really, you know, kind of tough health system. Nursing homes are tough. They're very highly regulated. They have a lot of challenges, but they're doing such great things for people who are vulnerable and often times at the end of life. So really wanting to have a very positive program in a really difficult setting was what we worked on for eight years and had very positive results in that trial. So it really is this idea of, of taking things and making efficiencies just like they have done oftentimes in those manufacturing type of jobs. So, you know, when Regenstrief became its own Institute in 2002, it's a nonprofit, it's a research organization that is meant to support and to provide that infrastructure to, you know, really make efficiencies in the research project. So one of the kind of unique things about being with Reganstreif is, you know, I have, there are multiple investigators, there's 50 or so investigators at Regenstrief. So when I finish, you know, learning from one on one trial, I can then be moved to another trial and be able to take with me those experiences that I had on those first trials and then apply them. So I'm not, we're not always constantly retraining new coordinators. We have a wealth of knowledge that continues to grow because we continue to keep staff in one kind of environment, one, one organization. And that's true with both, uh, HSR health services research organization. And they're working primarily with our VA. We've got a very robust, you know, aging research group. That's looking from everything from dementia to delirium, to, you know, using AI with, uh, older people to aging healthy. And so I can take those skills that I learned on one trial and transfer them to the next trial with a different investigator to help really hit the ground running. And so that's something that I think is a little bit unique about working in this research institution that supports an academic research program.
Brad: Right? No, and that's very cool. I mean, I spend a lot of time talking about more of your sort of independent site organization. So something like this is sort of a, a hybrid between, you know, your standard academic model and then your sort of standalone private research site. Uh, so it's very interesting. It sounds very interesting to me that you guys are able to work with, you know, maybe multiple groups, obviously multiple within those groups, uh, and sort of bring together those partnerships. It's very interesting idea and something, I don't know that I've specifically thought of, does it, is it, do you guys find it difficult to work with these sort of larger institutions and sort of any red tape that comes up along the way?
Laura: You know, we navigate those as we need to, but by having this partnership with Indiana university, you know, we, we are affiliate status. We, you know, utilize part of their infrastructure. You know, my emails through Indiana university, we get to take classes and trainings through Indiana university. We utilize their human subjects office. So we're, we build those partnerships to overcome some of those barriers. Um, you know, oftentimes people don't realize that I'm not part of the university that I actually am employed by a different organization. And, and by having that seamless transition by working in that community and, and really does go to the research community, we, we, you know, you don't see the difference of who your employer is, but rather we're part of that general university research community. So, so a lot of those have been navigated over the years as we continue to work. Side-by-side
Brad: Sure. No, that makes perfect sense to say. It's just interesting. I've never really thought about partnership quite like that. So again, you're sort of integrated within, but still standalone in some ways I assume.
Laura: Yeah, absolutely. Absolutely.
Brad: All Right. Well, that's very cool. That's a, and again, that's sort of the beauty of clinical research is like, you know, we talk about institutional sites when we talk about private sites and nonprofit sort of in between the two. So, you know, there's a full spectrum of where you can really land depending on what your specific interests are. So I think this is awesome because I think this is a completely unique perspective compared to anyone else, you know, that I've I've had on here. So I find that again, super intriguing,
Laura: It has been fascinating for me being kind of naive and, you know, kind of novice to research to come in and be like, well, doesn't everybody work like this isn't this how everything works. Um, so I really have that, uh, perspective that I can appreciate what the unique challenges, but also the opportunities that it brings. So, you know, I, I'm really grateful to be able to work really closely with colleagues at Indiana university and, you know, utilizing the expertise of the auditing office, because with, uh, investigator initiated, we're doing a lot of our own kind of, we have every part of the process that we're responsible for. So having to do our own monitoring and auditing, we don't necessarily have an external CRO or CRA coming in and helping us with that. And so, well, how do you do that? What do you do? How do I learn that? Where can I go take a class? Who at the university has those resources that I can ask about? And it really does get into what I find fascinating with research is just like you and I were talking about before the networking and the getting to know other people and, and what, what are they doing and how do they do it, and how can I, you know, beg, borrow and steal into, uh, help my own processes on the projects that I'm working on. So that part of networking and, you know, hearing everybody's unique experience, uh, has been fascinating. And I really enjoy hearing those stories from others too.
Brad: Sure. Yeah. I mean, again, you know, regardless of how diversified we are, I think that we do share a lot of the same, same challenges and the same successes for that matter. So, I mean, that's, uh, you know, that's the why I'm doing this so we can, all, we can all sort of, you know, live through each other's experiences in some way and sort of take what we can without necessarily having to always reinvent the wheel. So that's, uh, that's what I love about, you know, talking.
Laura: Yeah. That's one of the challenges I do still see about research is that, you know, trying to convey that knowledge to other others who are in the field. So, you know, networking can only get us so far until you, you know, find the right person that you need to talk to. And then that person is helping you to kind of think through your problem or your process, but really to, to help, to set some foundations for training and, and set some benchmarks to, you know, to be, you know, if you want to go into this route, these are some classes or some trainings or some resources to really start with so that you don't feel like you're constantly having to find the right person who has the answer or find the right person who can help you out with that question. Um, that really is one of the areas that I think is a challenge, but I think it's something that we are-like this podcast, like the, the professional organizations and the trainings that, that are being held and convened, I think they're really helping to solve this problem.
Brad: Sure. And to speak to that, let's say you're a part of the SOCRA board of directors, is that right?
Laura: Yes, I am. I'm currently on their board of directors and I've, um, also participated in, and my road was so crisp and fun because it really was out of a challenge that I got involved with that organization. So again, new coordinator, not quite sure what I was doing. Didn't quite know who to call, knew my research organization, but wasn't really tied in yet with the university, went to SOCRA and said, do we have a chapter here in Indiana? Um, and they said, Nope, do you want to start one? And I said, yes, I do. Um, and so we started a chapter. I was the first person to do our, uh, talk at our chapter way back when we started at, and I, I grabbed one of my colleagues at Indiana and said, Hey, I don't know what I'm getting into, but do you want to help me start a chapter here in Indiana? And she willingly and graciously said, yes. And she's she and I had been kind of working on this for about the last six years or so, but really trying to bring a training forum, for, for the membership. And what I love about the professional organizations and this community is it's open to anybody, right? Like if you find a topic that you need or want to go see you go to it, you go, you, you start attending. And so having that kind of open community to start talking about these topics and, and bringing speakers and, and, you know, I, I've always had the belief that everybody is an expert at something that they do in their job. There is an area that you are expert at. So come and tell us about it so that we can learn from you.
Brad: Yeah. And that's been no, that so much of the industry seems sort of siloed in ways. I really do. I think everybody's hungry for more, more information and you know, what else they can do to help be better at what they do within the clinical research industry. So that's something I think I've definitely experienced as well as that. There's a, everybody, I think everybody's out to learn more, which is very encouraging
Laura: Well, and, and, you know, COVID has been such a interesting time and we've been, you know, have faced a lot of challenges, but it has opened up opportunities too. So, you know, we went from in-person captor meetings. If you could attend, if you were local, we had some groups calling in, but it wasn't always as easy, you know, now with our zoom platforms and with some of these technologies, we're able to host meetings with, you know, a hundred plus people multiple times a month. That's pretty low bar to be able to host these and get, get them out there. So really feeling like we can contribute, even when we're kind of still, you know, I'm still at home, we're not back in our office or our clinics yet for my study. So for us to be able to continue to offer those, those educational environments, those opportunities to network those, you know, seeing familiar faces, seen familiar names that we had seen prior to, COVID still maintaining those relationships and knowing that there are folks out there that we can continue to call on and seek advice and consultation and just comradery with has been, has been good. I agree. I'm getting into zoom fatigue, like everybody else, but, but it also has been feeling like there's something we can be doing when we're still, like I said, still at home and still a little bit more restricted in what we're able to do. So that's been, that's been good. I've been, I've been hopeful about that.
Brad: Sure, sure. Yeah. I guess a silver lining then there it is.
Laura: We, we got to find them, we got to keep looking for them.
Brad: That's true. Okay. All right. So tell me what's, uh, if you had to share one best practice with other sites or research professionals, what would that be?
Laura: Um, I mean, I already talked about the networking, um, which I, I really do believe in, um, after getting into research, I went back to get my master's degree and I actually got my master's in communication sciences because I started to recognize that, you know, how we interact, like we've been talking about here, you know, that the training pieces and the interpersonal connections with others in the industry and connecting with our patient populations, those who were trying to recruit into studies or maintaining recruitment through the duration of study enrollment, you know, those messages are really unique. Looking at health literacy, looking at how much we use acronyms. And when we talk and how, you know, abbreviated our languages, are we really getting across the messages that we want to, to the audience that we intending it to be communicated with. So really started thinking about this idea of how do we engage with our colleagues and our participants. And so communication has been a huge kind of best practice that I continue to think about for each kind of step of the process. So who am I communicating with? What is my message that I am communicating? Am I listening and hearing effectively? What I'm receiving back from them is an engagement and a collaboration that we're both feeling? you know, we're getting the information or the knowledge or the experience that we both need to be passionate and fulfilled in whatever the, the encounter is. So, you know, networking, communicating effectively. Those are two really kind of corner posts for me in this industry. A lot of the rest of it falls a place when those are done well. And, you know, communication is one of those soft skills that we talked about. You know, we, we had the classes in high school, the communication classes and things like that, but really hone those and really be purposeful and meaningful with our communication. I find it fascinating. I find it so valuable for me to do my job well.
Brad: Yeah, no, I think that it's very much underrated and it's something I've sort of been putting in my mind lately, is that, I mean, to a large degree, clinical research is a lot like customer service.
Laura: Yes it is.
Brad: I mean, when you think about the elements of customer service, you think about understanding, listening, and responding in a way that, you know, relates to the person you're talking to and, you know, being able to serve them the best way that you can and the way in which they need to be. So I think when you sort of take that mindset with whether it's with your investigator or a sponsor or a patient, uh, you know, I think it, it crosses all those boundaries. So again, I mean the, not just communication, but the, the way that you communicate and, you know, with keeping in mind who you're communicating with, you know, is a very underrated skill to sort of have that emotional intelligence, I guess, to discern the difference.
Laura: And with communication, you really do get to your authentic self. You get to who you genuinely are, communication. Isn't one of those things that you can actually fake really well. It comes through very clearly. So if, you know, if we have our subjects, our participants, as our first focus, when we're recruiting the language looks a little different, it doesn't look like the informed consent forms that we have to get signed that feel like they've been, you know, massaged and kind of manipulated by whomever was looking out for a very specific purpose, the conversations around informed consent and good quality informed consent look really different than the forms themselves.
Brad: Sure.
Laura: So trying to integrate that personal, um, you know, that's why we've always, you know, now I know that we're getting some technology resources in with informed consent, but we've always typically done informed consent in-person with the person sitting next to you and having a conversation and really focusing on, well, what is, what is the ask of that conversation? What do I hope that I get out of it as the research professional and what do I hope that the participant gets out of it? And if am I conveying, you know, the trust and the relationship building that I hope a good informed consent conversation is intended to do, am I doing that well and doing good by the person that I'm speaking with? That really puts a whole different dimension on getting informed consent, right? Check you box that regulatory requirement. It's a whole different component. It's a whole different way to look at it. And I find it fascinating as we continue to move into these high quality interactions with our participants, because that's how we're going to insert trust with them. That's how they're going to want to engage with us for future trials, or if they're, you know, presented studies in the future, that they will be able to, to know that this is a trustworthy activity for them.
Brad: Right? Yeah. I mean, I think, you know, sometimes we, uh, we're too clinical in clinical research, you know, it is about building that, that trust in that relationship. I think with, with your, your patients, that again makes all the difference between whether they remain in the study or end up dropping out early because they don't, they aren't getting the, the attention or they're not being, you know, sort of served the way that they need to be. So again, I do think that's a ridiculously important distinction. That's, you know, it happens to all of us, you know, we get, we get going in our jobs and we're talking to patients and it becomes a little robotic sometimes over time. So being able to sort of stand back and like you said, do I think that your remember the values that, you know, you have and that you're, you're including in your work and a lot of that can, can be, you know, sort of brought back to center if you will.
Laura: Yeah. And, and, you know, it is a heavy lift for clinical research professionals to all the things that we have to remember with the regulatory requirements and the protocols are, you know, hundreds of pages long, and it is a big job. And to add one more thing to that and say, okay, now don't forget about the patient. This is, I mean, I recognize how that sounds so simple to say, of course, we're going to remember that, but there are a lot of demands in this job and to navigate gracefully, all of them is hard. And so it does deserve the acknowledgement and the credit that it is a hard job and people are doing it very, very well.
Brad: Yeah. No, no, no question about that. So what are some resources you use in your job or anything you find indispensable that you'd share with the greater clinical research community?
Laura: Yeah. Funny, you mentioned, um, you and I were talking in the intro or before we started about podcasts, I'm a huge podcast connoisseur. I find podcasts incredibly entertaining, but also really helpful to think about different topics in a new way, but also to do it while I'm multitasking. So it seemed to practice on those commutes and when I'm walking the dog and when I'm making dinner. And, um, I'm really excited about the boom in podcasts. So I do have, you know, I have my entertainment ones, but then I also have some kind of more leadership and business oriented podcasts that I do think. And interestingly, project management podcasts really aligned well with what we do in research to think about the process, to think about how to streamline what we do, because we have so much to do, how do we streamline or have activities do double duty for us to make us work smarter, not harder. I know Edye said that last time. So, you know, I think that there are things out there. There are tools out there that look at them with the lens of our profession really, really is a valuable resource out there. Like I said, I'm a huge communication advocate. I really think communication has a lot to do with every aspect of this role. So I have glommed onto, and I've championed the AHRQ health literacy toolkit. I have a copy on my desktop. I go to it probably once a week. It has wonderful tools and just ways to think about communicating with our subjects and our investigators in a way that meets those needs. So it kind of does the, um, takes those soft skills and really put some tangible metrics around them and tries to help understand how to, how can I do this better? What are some tools to be able to do this better? I've been a huge champion of it for years, and it it's a great resource as a free resource. It's just out there definitely would encourage everybody to look into it. And then honestly, I look for any kind of templates out there and I try and contribute as much as I can to, you know, what is somebody's done before that I can use to modify rather than starting from scratch. So, you know, my grants are funded through the NIA. So I typically use the national institutes of health website and they've got templates on there for a lot of stuff. I'm so really starting to say, okay, let me see how I can work smarter. What can I find on the internet? What can I modify to meet the needs that I have so that these task level responsibilities become something that's very routine. And I can then spend more energy and time on some of these other bigger, more complex issues, like how to increase in recruitment in a population that maybe is hesitant to talk with me, or, you know, where do I need to expand my enrollment to meet those numbers that I have this month? Or what have you.
Brad: Are there, are there any specific podcasts you'd call out just out of curiosity?
Laura: Um, so I really like Unlocking Us and Dare to Lead with Berne Brown because she's a, um, a researcher out of Houston. She really combines the topics about vulnerability and leadership and gives all the research evidence and backup that we like as researchers like to hear about too. So she's one of my favorites. I love listening to, um, 99% Ynvisible, it's a Radiotopia podcast and it talks about design in our everyday life. Um, so it will talk about things like how sidewalks are structured to accommodate people with disabilities. And these are the design features about that. You don't maybe recognize because it's invisible to us. We just assume that it works. And so I find that podcast incredibly fascinating. Um, You're Wrong About is a podcast hosted by a writer for the Huffington post. And it talks about stories in pop culture that we thought we knew. Right. But we actually probably don't know. And so stuff you should know and just all these podcasts about kind of everyday topics that I think I know about, but really, I don't really know all the ins and outs because I'm not an expert in them. Right? Like I can't know everything. Um, so I really find some of those kind of where it's just everyday things that have been explained to me in a different way. Um, I find those fascinating.
Brad: Awesome. I'm always looking for more, more podcasts myself, so glad to get your, uh, your opinion there. So that's awesome.
Laura: Yeah, The, the, the downside of it is that there are so many podcasts out there that then I become sad that I have to miss listening to all of them, because I do want to there's too many choices. Which one I going to listen to today? Um, no, I really do find listening to podcasts and learning, you know, on those kind of unique times, those times where I didn't think I would be able to engage in something like when I'm doing dishes. I really find that as a rewarding outlet.
Brad: Yep. I'm right there with you. Well, very good. Well, tell me where can people find you online, Laura?
Laura: Yeah. Um, probably my most active is on LinkedIn. Um, I do have a profile there. I, I typically will respond to messaging direct messaging in there, but that's usually the easiest place to find me as is on LinkedIn at this point.
New Speaker: All Right. Very cool. Anything else before we go?
Laura: No, just thank you so much for having me on and I really enjoyed the conversation.
Brad: Yeah, me too. Thank you so much. And, uh, we'll talk again soon. Thanks, Laura.