Episode 22: Trevor Cole, BHS, MBA-HCM-PM, CCRC, PMP

Trevor Cole is a manager for a research quality, monitoring, and regulatory affairs service line at Children’s Mercy Research Institute in Kansas City, MO. Prior to this role he has worked as a CRA/CRC in Oncology, CRC in gastroenterology hepatology and nutrition, managed a multispecialty health clinic, and worked in an emergency room. He holds a CCRC through ACRP and is currently working through nursing coursework which he will complete in December 2021.

 In this episode we discuss exposure to clinical research as a career at a young age, the lack of standardization and the top-down nature of the clinical trial industry.

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+Full Episode Transcript

Brad: All right. Trevor Cole. Thanks so much for coming on today, man.

Trevor: Yeah no problem. Thanks for having me, Brad. I've always listened to this podcast and wanted to be a part of it. So thanks for having me.

Brad: Awesome. I appreciate it. I'm glad some people out there are listening since you never know you just, I never, uh, never am sure how much people are paying attention out there. So that's, uh, I appreciate that. Are you, uh, we talked a little bit earlier. You still, thawing out up there and in Kansas city?

Trevor: Yeah. It's, it's warm, been warm for the past two days. Um, we've had some nice spring weather, but before that we had quite a bit of snow. So we're are a blessed and trying to enjoy the warm weather as well. While we can.

Brad: Yeah. I think everybody's happy to sort of slowly start to get back to normal life. We were out for a good, good week, almost a week and a half with some of the ice that came in the week before that. So it's been just one more thing. We don't need it with everything else going on in the world right now.

Trevor: Yeah. We all need to get some vitamin D with the sun, so

Brad: Yeah, that's true. Get out there. Well, very cool. Like with all my guests, I like to, uh, just kind of start out with, you know, tell me a little bit how you got into clinical research. I think that, uh, you know, I've, I can't say it enough, so many diverse backgrounds and sort of interesting stories I think people can relate to. Uh, so tell me a little bit about your background and sort of what brings you where you are today?

Trevor: Yeah, so I kind of initially started in healthcare. So I joined this program when I was in about the eighth grade. Um, there was this program that they had called the area health education center, or AHEC is what they call it for short. But, um, it was this program that was funded by the state of Missouri and you had to apply for that and interview and then they allowed so many applicants to be part of this group. And so what you would do is monthly, they would have webinars, or they would have actually in-person conferences at local hospitals. And we would learn about healthcare careers. We hadn't reached kind of assigned a counselor. And so that's really kind of where wearing that into healthcare in general, my, my mom's always worked in healthcare. So I knew that was where I wanted to go with my career. But, um, their health education center kind of opened my eyes to all of the options within healthcare we have and including research. So that was really the first time I even knew that research could be a career option for me was when I became part of A HEC group. And then I actually kind of wanted to be a physician that was kind of my plan. I applied for this, uh, summer scholars research program in the summer between high school and my getting my bachelor's I'm an undergrad. And so I was accepted into that program. And so we actually were assigned to research studies and the one I was assigned to was coping mechanisms, um, and stress and family caregivers of terminally ill individuals. So, um, you know, early on, I got some experience consenting and recruiting participants, um, having that, that dialogue and kind of what went into collecting data. Obviously we were not using very much electronic stuff back then, but, uh, yeah, so I learned all of that then, um, I was really interested in, and I didn't really get to see the backend of best study just because it was just a summer research kind of program, but that was kind of where I really got my first hands-on experience within research. Um, and then during college, um, I had several different healthcare roles. I worked as a dental assistant. I, I worked in as a detox treatment at attendant, which that has some interesting stories to it, for sure

Brad: I can imagine.

Trevor: And then I worked in the emergency room for most of college, um, as a technician there, again, some really good stories. Um, but I kinda, my focus really was to try to be as well-rounded as I could, like while I was in college and be able to get some really good experience in different healthcare fields, hoping that, you know, I would find my passion as I was going through all that. Um, and so really, I, I kinda just liked it all. I kind of liked everything, but I completed my bachelor's and it was in, uh, I did pre-med, it was kind of pre-med they call it health sciences, but it was a pre-med, um, degree track. And I applied for a job as a research assistant, um, when I was completed and I got that job at the children's hospital in Kansas city. And so I began working there, um, and it was in gastroenterology, hepatology and nutrition. so at that time, as a research assistant, my main focus was focusing on like study startup activities. Um, I did some registry studies collected blood samples, and I did some laboratory processing and then also recruited participants for active studies and then did some data management. So that was kind of what happened as a research assistant in that role, a lot of different things. And then about eight months after being in that role, I transitioned, I was promoted to a clinical trials coordinators, what they call that, um, at our institution. And so, um, at our institution to the clinical trials coordinators or clinical research coordinators, they kind of manage all the processes of the study. So I know that that's different from site to site, but we did everything from startup and helping with protocol development to consenting that the participants collecting study, visit activity and data, and then also the study close out, um, stuff. So, so yeah, we have a broad set of things that we were responsible for there. And I did that for quite some time, decided to do, um, get my MBA in healthcare management. So I started to do that and I was offered a position as a clinic manager. So I got out of research for a little bit, and there was a clinic manager at a multi-specialty clinic, um, and decided, uh, I shouldn't let the opportunity pass me by, um, as I was getting my MBA. I thought that would be some good, uh, experience to have under my belt if you will. Um, and so I did that for quite some time and finished my MBA in healthcare management. Um, and then after about 18 months of working in that role, um, the company I was working for actually was, um, about to transition and no longer had those facilities. And so, um, I got a call from a friend that I used to work with at the children's hospital and, um, they had another research position opening. So, um, I went back there as a, uh, I entered a little higher level. So we have on the levels we had at the hospital was a one and a two. And so clinical trials coordinator one and two. And so I entered as a to, um, and again, that was in gastroenterology, hepatology nutrition, um, doing a little bit different work at that point in time. And we had some IUD studies and it's a little more complexities in that role. Um, I did a lot of the manager left there, so I had a lot of in term management experience within research during that time they looked for someone to fill that role. And then after about two years in that role, I was, I had actually transitioned internally to, um, be a CRA that was in our oncology department.And so I always wanted to, um, you know, get the experience of oncology, um, on the research side, because it is a different world that's for sure. Right, right. And so I was able to transition over there and, um, I was completing my post-master's certificate in project management while I was working in that role as well, which has been beneficial throughout my career to have those skills and project management. So I worked in oncology and, you know, I loved the work that I was doing there. We do a lot of cogs studies, our children's oncology group, um, maybe don't know what ONCOG and, um, you know, it was definitely a tough role to be in. You have to, um, see these kiddos and these extremely horrible circumstances. But, um, you know, at the same time we got to be engaged with them and give them hope, which was amazing. So, you know, I loved that role. Um, and I worked over there for a while and then this position that I'm in now, um, opened, and it just felt like it was kind of meant to be, um, because during my whole career, I was very interested in improvement. So, you know, as a coordinator, this, we, as part of a small organization, there were a lot of things that we didn't have. You know, we didn't have standardized processes, we didn't have a lot of templates or forms. Um, we didn't have really good, uh, processes to follow or SOPs. And so I feel like over time, you know, I, I kind of focused on what can we do to improve the current state of how we're doing our work. And so that was kind of one of the things that helped me decide that, yeah, I wanted to move into this new role as the research quality program manager, I'm at where I'm at now. And so since joining that program, um, which I've, I've been managing that program for about two years now, we, over those two years, we've, we've doubled our monitoring efforts, um, that we're doing internally. Then we expanded to include other quality offerings outside of just our routine monitoring that we would do. That's, risk-based, we've developed a lot of SOP, some standardizing guidances. Um, we've standardized some of our internal, uh, ISF filing practices. That was a big project we worked on. Um, and then also developed a lot of quality means tools and a framework, um, to utilize. So that is, um, you know, currently kind of my background and research in general, and again, kind of my, my background in healthcare, which has been really a focus to try to get a little bit of everything in my toolbox.

Brad: Yeah, no, I mean, it sounds like it was a, you know, sort of long and circuitous route. I mean, I kinda, I, I love that, you know, you're exposed at least to the idea of clinical research at such a young age. I know when I first got into clinical research, I was like, what the hell is this? I've never heard of this before, you know? Um, so, you know, that's really cool that at least have that, you know, sort of knowledge in your back pocket, you know, at, at, at such a young age, and then I can only imagine how all those different roles along the way kind of helped prepare you by. I mean, if you can be in an emergency room or in a, you know, a detox center situation, then you can probably handle, you know, the pressure of dealing with a complex protocol, a lot more easier than, you know, somebody who hasn't had that sort of clinical experience.

Trevor: Yeah, yeah. You absolutely have to be agile and be ready to adjust and adapt as things come, which has been, you know, you have more, uh, I think helpful recently with the pandemic, you know, we've had to do that in research. Um, and so my research is always changing. That's nothing new. So, um, you always have to be able to adapt and, um, changed your protocol. So yeah, I think that I think that definitely has helped.

Brad: Yeah. I think it's been, I mean, if there's a silver lining and in the whole pandemic, I think it's that it's, it has pushed everyone to do things a little bit differently. And, but, you know, predictably it's, it can sometimes be a mess cause you've got sponsors trying to do things differently using different systems. But I think the idea that at least everyone is saying, Hey, we need to do, we need to bring something new to the table to keep these projects going, because, you know, you can't drop everything, you know, just because of the pandemic, other people that need help, there are other diseases and illnesses that continue to exist. And it's been a very, it's just been a super interesting year, you know, watching things sort of slowly evolve as, you know, the pandemic sort of lingered on.

Trevor: Yeah. I totally agree. I mean, it's been like, you know, with all the kind of push towards decentralized trials, um, and, and all that, I think we'll be seeing a lot more even standardizing guidances and practices that are coming out around that. But with tele-health in general, there's just so many complexities, you know, so many, um, I think even in the healthcare realm, you know, they haven't been able to come up with a great practices around that just because there's not, um, standardizing regulations from state to state. And so that's, that's kind of been a barrier. Even within healthcare. We had a story where, you know, we had a family that had to have a telehealth visit and they had to just drive across the state line to have that visit and then drive it back. So they were in a parking lot, literally having tell out visit, um, drove back across the state line to their home. So, um, you know, that's crazy. So it's interesting, you know, that, um, I think that not just research can learn something, but, um, you know, healthcare in general, we can, we can take a lot from this experience and hopefully improve processes for our patients. I mean, at the end of the day, what matters is the care we're providing, right. And if we can't do that, uh, because of these barriers, we need better policies and regulations around that.

Brad: Yeah. No, I mean, that's, that's absolutely true. It's all, it's all about how I think we can improve the experience for the patient. And again, I think it's super promising if you look, you know, I spend a lot of time on LinkedIn. I mean, it's a huge topic of conversation. It's, uh, everybody's putting a lot of time and energy into improving the patient experience, whether it be through, you know, increasing diversity or decentralized trials and all the different things that that entails. Uh, so I think we're on the way, you know, and I can't see things really going backwards at this point. I say that, and I'm going to knock on proverbial wood because you know, who knows the crazier things have happened, but it seems like we've at least had the catalyst to really push things and, and continue to improve that connection now with, with patients. So again, it's, uh, nothing else. That's a little bit of a silver lining of, of the last, you know, 12-15 months.

Trevor: Absolutely. And we've seen like all this synergy around it too, which is nice from so many different stakeholders have kind of embraced it. So that's kind of nice to see.

Brad: Well, yeah. You know, I mean, you know, I work at a site level like you, like you do. So I always, I find it a little bit like puzzling sometimes like if pharma wanted to change things, I mean they could do it. Yeah. Right? They've got the resources, they've got the money, they it's in their best interest really. So it's just a little bit, you know, befuddling, to me that it hasn't happened sooner or quicker. Um, and maybe I'm being cynical, but there seems like there's, it's just odd to me that the people who really hold the purse strings and who have the most to gain, you know, haven't been more proactive in, in doing these things because, you know, at a site level, we are pretty much at the mercy of what sponsors tell us to do to a large degree. Not always, but you know, we can't just use any EDC we want, we can't just use any ECLA. We want, you know, we are using what they give us to use.

Trevor: Absolutely. Yeah. It's, it's definitely NH internal, you know, we, I know we have so many resources around, you know, even looking at say there's a new EDC we're going to be having to use from a sponsor or a new e-consent platform. There's so many internal resources, even at a site level that go into that into, you know, making sure that it fits, we are a covered entity. So HIPAA applies to us. So making it fits within, you know, um, what we can use to, um, to the, and what risks we're willing to take as an organization. So I think that that's been definitely a complicating factor, um, as well as, you know, making sure there's so many options, there's been so many options that have popped up of, um, systems that you can use for, you know, irregulatory or, um, EDCs. There's so many options out there. Um, and so making sure we're all picking the same one, cause if we pick different ones, we have, they may not be able to integrate with each other. And so that's been another big complication, I think, um, technology that we'll probably eventually see change because that's, what's going to have to happen at some point is we're going to all have to standardize what we're utilizing to, um, make sure it's in the best interest of our, all of our resources.

Brad: Yeah. And that, that's a really fair point. I think I might just be aware we are on the timeline like right now, you know, everyone's jumping up with a new solution, but eventually there's going to have to be some consolidation because again, you can't have, you don't want to have 50 CTMS and you don't want to have 200 EDC systems because it's just ridiculous. I mean, it's, you know, it's ridiculous the amount there are before all this happened, you know, having to have a, you know, 50 different passwords saved for all the different systems and all the different studies that you're working on is seems just archaic, you know, it's, it's nuts.

Trevor: Yeah, absolutely.

Brad: Well, I would say, I'm curious to know a little bit about your role now. Um, are you, are you able to sort of help standardize what goes on within the multiple or various departments within like your Institute, for example?

Trevor: Yeah. So, um, I'll tell you a little bit about just the program itself. So we've, we've had the program at the hospital since 2015, um, and it's, it's similar to your traditional. Um, they started out similar to your traditional PAM programs or post-approval monitoring, and it's kind of morphed into, to being a little more than that. But the program initially I took, um, there's a risk algorithm that we use to, um, score studies, um, that are coming through our institutional review board. And so we score those for, um, those risk categories that we have set. And then we do monitoring based off of those high risk studies. Um, and those, we call that routine monitoring. So we'll just go through, and it's a little bit different than your, if your sponsor was to come in and monitor because we're not just looking, you know, at the study itself, but we're also looking at adherence to internal policies within our institution. And so it's a really good opportunity to support the study teams, you know, in a way that's non punitive. Um, we're there to help them and give them the tools that they need. Um, it's also a great way to educate and real person. I know. Um, you know, for me in research, mentorship is huge. Um, I, I was lucky enough to have a CRA when I was young in my clinical research experience, I had a CRA who was, um, very hands on and helping me and I'm explaining things to me. And so I really wanted to make sure in our, our role that I'm in now, that we actually are the same way with our study teams and that we provide them with good rationale, um, to help them understand and then improve when they do the next fee. So what we do after that is we kind of do, um, we'll go in and do two days typical of our monitoring depending on the study, sometimes it's longer, but, um, we monitor, um, uh, study management, subject management and data management. So we're kind of looking at all those areas of the study and then we zoom in on areas of high risk. So those errors that matter, that's kind of what we're trying to focus on when we're doing our assessments. And then we kind of meet with the teams and go over any observations that we may find or opportunities for improvement, best practices, um, as a institution, that's one of the, that's a hard part is we have things that are regulations that we have to follow. We have guidances and then we have best practices. And so, you know, best practices may vary from site to site. And, um, that's something that we've been able to really try to adjust and, and come up with what's our best practice as a site. Um, and that changes, right? I mean, as new technologies emerge or any process improvements emerge, we may be able to implement new best practices. So, um, that's been another big piece of our program. Um, and so since then we also have added in, we do quality, um, kind of start-up consult consultations where we'll meet with study teams to be proactive and their quality management. Um, and then we're gonna, you know, obviously focus on mitigating any of those errors that would matter, and the research that we're doing, um, so that we can focus on that production of our high quality research. So we try to do that prospectively as well, because typically when we're doing monitoring, we're hitting, you know, a study somewhere in their, their life cycle of already starting to recruit. So we may find some things that would have been nice to know that before. Right? And so we tried to add this, this option in, for consultation early on and kind of the next step is to embed that into culture, right? So not just have that as an option through our, our QP or research quality monitoring program, but, um, to also have that as a part of what we do every single day and in the research that we're doing. So to have solid scientific merit and feasibility processes embedded early on that, um, also focused on quality, so that quality by design component, looking at that early on, um, in study development, as you can adjust, you know, you may be able to adjust the protocol early on to avoid having potential errors.

Brad: Right, right. So do you, are you guys primarily more working with, uh, like external pharma sponsors or is it, are these mostly grant funded or investigator initiated type trials?

Trevor: Yeah, so we do, uh, we do all of it actually. So we have, um, we have a lot of investigator initiated type of trials. Um, but we also have a lot of sponsored, um, and a lot of grant funded research. So we do a little bit of all of that when we do our research monitoring, most of our quality supports had been investigator initiated type of studies, just because those are the ones that usually, you know, you're building those from the ground up. And so they do need a little bit more support and experience. And if you've never developed a, or even seen, you know, really good sponsor protocols, then sometimes you don't know what you may need or what you may be missing. And so, um, that's, that's something we can kind of bring to those teams and, um, consult with them on adding, Hey, if you would add this to your protocol, um, you would possibly mitigate any risks down the road. So, um, but yeah, w-we do do a lot of monitoring also on the sponsored studies, even if they're monitored externally by the CRL, we still come in and do our internal monitoring, um, on those types of studies because we still find errors. That would be something that we opportunities for improvement that would be something we could address or to discuss with the study team. And then we can bring that back to our institutional level and research administration and say, here's the data we're seeing kind of across the board. Maybe we can Institute educational opportunities or new new policies or SOPs that can help move this thing that we're currently in the red on into the green or something like that. So we can kind of hopefully change over time to improve those gaps that we see.

New Speaker: Yeah. And I mean, I, I love that. Especially being sort of, uh, you know, very prospective, I think, you know, I work now primarily with, with pharma and device companies. I used to work a little bit with, you know, investigator initiated trials. I know they can be different beasts, but they also share a lot of similarities, but, you know, so often I think you get a protocol, you know, even if it's a great protocol from a CRO or a sponsor, and there's a lot to consider when you're getting ready to start a trial. And I think we have all also seen that sometimes you don't know what you don't know until you really get into the, to the meat sort of, of the study. Uh, so having some time, some outside perspective or a perspective that's, you know, obviously specifically trained to look at and anticipate these things, uh, can go a long ways. And then especially when you're dealing with different departments who may have slightly different practices, uh, and being able to sort of, again, standardize those things as much as possible. I mean, that's a huge benefit. I know for me operating multiple sites, that's something that I struggle with and really need to continue to strengthen is sort of keeping some standardization across multiple sites, just because it's, uh, you know, that sort of Kaizen concept of like continuous improvement. And then, like you said, taking it back to the top and saying, okay, this is what we're seeing. These are the trends, what resources can we use to fix these and make them more efficient? So, uh, you know, I, I love that sort of continuous improvement model. I mean, I think that's speaks a lot to what you and your institution are trying to do.

Trevor: Yeah. I think in research, um, you know, like this idea of lessons learned and how do we capture that, you know, um, I think that's, we definitely still have yet to be great at that, um, at our institution. And I, I, I'm sure other institutions struggle with that too, is how do we take all this knowledge that all of our, all of our study teams have and all the lessons that they come with, that they may know that someone else may not. And how do we consolidate that into some sort of knowledge management system to share across the institution and, you know, really help impact the quality of what we're doing and in the logistics, because there's so many stakeholders within research, I oftentimes kind of refer to it as like, you know, you're juggling stuff and there's so many, the more balls you add to that, you're juggling, you're eventually going to drop something if you don't have solid processes and that you're going to be continuously checking in on those things. So research is not an easy, easy career, but it definitely is something we can manage. Um, if we're doing that prospectively and we're really focused on the focus on the planning of the study itself.

Brad: Yeah, no, that's exactly it. And I think that's sometimes lost on, I know it's been lost on me at different points in my career is, you know, again, sitting down and bringing everybody to the table and saying, all right, let's work through this before we, you know, get up and go, and that alone can sometimes save you some pretty big headaches.

Trevor: Yeah. I had this, um, this one, uh, teacher when I was in my project management, uh, post-master's certificate program. And he would say, um, you know, we have, we have three options. We can have things good, fast or cheap, and we only get two of those.

New Speaker: Yeah, pick two. Right?

Trevor: I always use that kind of terminology when I'm talking to our investigators and especially, you know, at a site level. And if you are familiar with this is, you know, sometimes those resources are slim and so we have to have good, that's a given, right. So the only two things we can adjust are cheap and then, uh, resources are time. So, so those are the, those are kind of the things that we can wax and wane or change, um, to keep back that good. They're in the middle of that.

Brad: Yeah. No, absolutely. So if you were to share a best practice with other sites, if you know, any, even if it's something broad, like what's, what's something that you would, would share with other sites as a sort of general best practice.

Trevor: Yeah. So, I mean, I think it's important with, with best practices in general is, you know, definitely to start with clear expectations, um, you know, so look at your mission and vision, make sure that you're going to be living that out in your best practices, right? Whatever, whatever your mission and vision is for your organization, and then set those clear expectations and your job descriptions, um, making sure that we have solid training, that's another, another piece. Um, and then focusing on what matters most within our operations. So those, those are the things I think, to start with high level, and then you kind of want to standardize your internal practices. Um, so I think that's, that's key to consistent high quality delivery, right? Uh, of any product is, um, standardization, you know, establish some sort of reporting framework, um, and then facilitate support as well at all of those levels and then engage all of the team members. So I think that's sometimes what gets missed is not engaging all the stakeholders, um, and what's going on in sending those best practices. Um, and then also just being transparent and then focusing on that continuous improvement. So knowing that your best practices are going to change over time, um, just building a system that is agile, you know, will be, will be helpful and then just benchmark as much as possible too. I think that's another important piece of any best practice development is benchmarking, you know, that's your literature search and you're collecting all that information, um, and kind of compiling it and saying, what fits here? What does it fit here? Because you're ultimately trying to create best practices for your environment. Um, and then also I think it's important to use that data to drive those initiatives and priorities, um, within your operations. So those that's kind of my, um, I guess, advice on best practices in general

Brad: Right no. I love it. I think that's a very happy and that's very encompassing and, and succinct at the same time. I mean, that's, that's, I, I don't think I can even add to that. That's perfect.

Trevor: I think sometimes it gets, it gets missed, right? Like that the HR pieces of what we do is just as important. That's important to culture and culture is important to how we do our work. And so I think that that plays into best practices. You know, some people may not see how that fits you, but to me, it definitely, it definitely does. And that we engage our, um, you know, all of our teammates in what we're doing and that again, we'll create best practices and, and that culture of understanding.

Brad: Yeah. I mean, and sometimes I think it's as easy as just communication, constant communication. Uh, I think that's always sometimes undervalued, uh, in what we do, especially when there are again, so many different stakeholders, uh, when it, when it comes to these complex, you know, trials that we do.

Trevor: Yeah. We have, um, there's this presentation I do. And I show all of the stakeholders and you know, that we have within research just to help people understand that there's, there's so many we don't think about, right. We have army nurse, our institutional review board as a stakeholder are outside regulators. And most importantly, you know, are the public in general, um, you know, those journal publishing entities that we're publishing to, that's it. Um, another one that people don't even think about as a stakeholder. Um, so there's just so much, so many stakeholders involved, but I think sometimes we, we forget,

Brad: Right? Yeah, absolutely. It's never bad to have a reminder of, you know, all the, all the people involved. I love it. So what are some resources that, that you use, or maybe some things you find indispensable, whether they be a, you know, a book software or some kind of process, or, you know, anything else what's, what's something you'd share with the community that's really helped you be the best at what you do.

Trevor: I love, um, systems that work for me. Right. I mean, I think we all do. Um, and so Smartsheets is one of my favorite, um, technologies that I like to use. Um, I don't know if you've ever used that rabbit. No, I don't think I have as Smartsheets is, um, it's, it's pretty much a very sophisticated Excel, um, but it can do a lot automate a lot of functions for you. And so that's, that's probably one of my favorite tools that we use, um, within what we do. I also RedCap is another really great tool that I know a lot of people use out there and it's freely available and it has so many amazing attributes to it. So I'm, I'm a big fan of Redcap. And then I kind of, uh, also think that the FDA Bayamo, you know, observations I think are great to look at, and especially in my kind of field to look at those and be able to benchmark, but really even in operations or as a coordinator to be able to look at, okay, what are, what is happening out there? what is happening in the observations of that DAC and how can I potentially impact that, um, at our site and make sure that we're, we're hitting those big observations. And then I also think we have, uh, a couple of organizations we always look at. So I mean,CITTI, obviously that, um, clinical trials transformation initiative, they always have so many great resources. They're quality. My design initiatives are amazing for, um, anyone to kind of look at and share and utilize. Um, especially if you don't have any sort of quality framework, you know, what your institution, that's a good place to kind of start. Um, and then I also think TransCelerate has a good, um, quality management system kind of guidance. So that's another great resource. And then listservs, I, I think that there's so many listservs out there that people probably don't even know about, uh, organizations that are all these groups that kind of come together and tried to, um, impact something. So I know that at the site level, like we have a, um, clinicaltrials.gov task force. And so, you know, listservs like that, or the research compliance network, those, those types of listservs or networks are just so, so valuable because you get input from so many different leaders at other organizations. And so for me, that has been, you know, just a great learning opportunity in my career as well.

Brad: Yeah. That's, that's interesting. I don't know that I've checked out, we'll kind of listservs world. It's been some time since I've even heard listserv being, being used. So we may have to, I want to talk about that maybe a little bit offline. I'm going to get some, some tips tips from you there on that. Absolutely. But ultimately, I mean, it sounds like it that's about, you know, reaching into and sort of community and network, you know, to sort of get other people's perspectives and thoughts. So, and again, I think that's something that's extremely important in what we do is not, not staying siloed as much as possible.

Trevor: Yeah, absolutely. And that's, I think that's just, that's important. Right. You know, we, um, there's a world outside of our institutions and our organization, and sometimes that's the most valuable because we get a different input that we maybe wouldn't have otherwise. And then, you know, I think another piece that's just been so valuable in my career, that's totally outside of all these other resources we just talked about, but is some sort of positivity or leadership training. And, you know, so I think for me, it kind of started with John Gordon, um, has this, like these, uh, books that he's wrote and one of them is the energy bus. And so I think starting with that, as well as part of adding that as part of your leadership growth and learning about how to incorporate positivity in your daily work, that's just helped me be able to establish the relationships, you know, and work on my soft skills, which is important, so important to research. And sometimes I think it's forgotten, but soft skills are so important.

Brad: Yeah, no, that's awesome. And that's a great point. I mean, without getting too into the weeds, I mean, I do think mindset plays a gigantic role in what we do and, you know, the, the level of, of success. And obviously there's all kinds of different philosophies and programs and different ways of thinking, but just the fact that, you know, you found something that relates to you, uh, is, is awesome. And again, I don't think anyone's mentioned that yet on the podcast, so I'm actually really stoked that that's something you bring up because again, I think that's sort of something that goes under the radar for a lot of people. Um, I love that.

New Speaker: Absolutley.

New Speaker: Well, very cool. Well, tell me, uh, where people can find you online.

Trevor: Yeah. So I am on LinkedIn, um, that had been named Trevor Cole and then also, um, by email. And so I have, uh, my email is Cole, C O L E consulting, casing@gmail.com. Um, so those are kind of the best ways to contact me on LinkedIn the best, uh, obviously by email is a great option as well.

Brad: Awesome. We'll make sure to post that up on show notes, anything to say before we go. Um,

Trevor: Thank you for having me, Brad. I appreciate it as always good to talk to you and just keep doing what you're doing and impacting all those young researchers out there or experienced researchers that just want to learn a little bit more. So just thank you for what you're doing. Um, and thank you for having me

Brad: Oh, I appreciate it. Thanks for coming on, man. We'll talk again soon.

Trevor: No problem Have a good one.

New Speaker: You too

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Episode 23: Adam Brown, ClinArk

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Episode 21: Laura Holtz, Regenstrief Institute