Episode 05: Interview - Kartik Munshi

Today we welcome Kartik Munshi to the podcast. Kartik is the Research Operations Manager for the Cardiovascular Medicine Department at the University of Kansas Medical Center. I’ve known Kartik for several years and we worked together previously at the Oklahoma Heart Hospital Research Foundation. He’s been in clinical research for 10 years and has worked in a number of positions from clinical research coordinator to QA and compliance.

In this episode we discuss opening back up in the time of COVID-19, learning to let go of mistakes and how important it is to document, document, document!

Kartik can be found at LinkedIn here: https://www.linkedin.com/in/kartikmunshi/ and emailed at Kartik.Munshi@gmail.com

+ Full Episode Transcript

Brad: Hey guys. Welcome to episode five of Note to File podcast, a collection of interviews of best practices and ramblings for clinical research sites. My name is Brad Hightower. Uh, you can check us out at notetofileapodcast.com. Uh, thank you for tuning in today's our first interview. It's a good with a good friend of mine. His name is Kartik Munshi. Uh, we worked together at the Oklahoma heart hospital research foundation. Uh, he is currently the Operations Manager for the Cardiovascular Medicine Department at University of Kansas Medical Center. He's worked in clinical research for over 10 years. Super sharp guy. Let's check it out. Alright. Kartik thank you so much for coming on today. How are you, uh, holding up up there at, in Kansas?

Kartik: I'm doing great, Brad, and thank you for inviting me for this. I'm really excited.

Brad: Absolutely. I know you mentioned before we started recording, it sounds like you guys are starting to get back to work up there.

Kartik: Uh, yes, currently, uh, the policies are that, uh, We are, I mean, uh, we are allowed to come back to the campus, but, uh, as long as, uh, we can get our work done from home, a preference is that to stay at home, but if we have a patient with it to do, then yes, we are coming back.

Brad: Yeah. Now we're kind of doing the same thing down here, you know, as much as possible. I don't want people to be in the clinic any more than they have to, but, uh, at some point, you know, patients are starting to come back in and people are getting a little more comfortable, whether that's a good or a bad thing isn't real clear yet, but, uh, that's good to hear. And it sounds like there's a lot of studies coming up. So again, it's a good sign for the industry that, you know, studies are starting up or starting to, uh, continue. Uh, we had study suspended that we're still waiting on to start up again.

Kartik: Yeah. We had a we stopped actually all the enrollments and then we restarted, uh, like a week ago or 10 days ago, I would say. And then, uh, as far as like new study wise, I would say like a, it's a good news for the industry that, you know, uh, new trials are coming up, sponsors in the companies are, uh, willing to do more studies. So it's like we have to see how patients are interested now to participate.

Brad: Yeah, no, that's, that's been a problem for us. I know that, uh, we never really closed per se. Uh, but truthfully, I mean, we had patients who we couldn't get anybody in, even if we wanted to, to be up in the clinic. So it's, uh, gonna take some time till everybody's kind of real comfortable with the new, the new normal, if you will.

Kartik: Yeah

Brad: Well, very good. I know we've known each other a long time. We worked together at the Oklahoma heart hospital research foundation. Uh, I'm always kind of interested to hear about people's, uh, story of how they got into, uh, so if you will tell us a little bit about, you know, your history and how you got started on clinical trials.

Kartik: Sure. So I started as a student actually, uh, during my MPH, a two lane. And that time I worked on a study for endocrine department, it's called the Card study. And I used to basically interview patients for a sub study to, which was called memory in diabetes in short form was mined. So I used to interview and conduct different cognitive tests and kind of recorded record the interviews and send it to the coordinating center from there. My boss Roberta, she got me hired, uh, for full time, uh, uh, with cardiology department at Tulane. So that's how I started as a research coordinator at Tulane in then kind of, uh, uh, learned the tricks, uh, of clinical research. I, I was trained, uh, basically by robot I and one of my coworkers and, uh, on different, uh, uh, different processes of the clinical research, like IRB submission study startup in patient follow ups, you know?

Brad: So you got a, you got a pretty broad training from the beginning. It sounds like.

Kartik: Uh, yes, because of my boss, Roberta, she was also the IRB chair at that time. So, you know, that's what I have pretty solid. Yeah.

Brad: Yeah. Say that's a nice, a nice little bonus to have somebody who's on the IRB help helped train you. Yeah. Yeah. I think that's a always, again, that's always kind of interesting to me how different departments are broken up, uh, as to, you know, how specialized people are, uh, within their departments. Uh, so it's always inch.

Kartik: Yeah. Plus we were very small department there. Like, it was just say two coordinators and we had our boss over us. So pretty much both of us were responsible for, for all the studies and for doing all the work from like startup to the closeout. So

Brad: sure. And I always think that's the best system to learn anyway, is that you have everybody kind of do everything. Uh, it can be a little bit messy in the beginning, but you probably ended up with a lot better handle on how the whole process works. And she were sort of trained from the beginning to, to go from beginning to end.

Kartik: Yes. And initially I think I used to get a little frustrated with small things because, uh, I always, uh, wanted everything to be perfect, but then, you know, I had to kind of learn that sometimes it's okay to make mistakes and you know, you also have to learn how to fix it in the right way. So I think,

Brad: yeah, that's true. And I think that's, it's an important point in what we do where, you know, all your work is checked by him monitor or CRA, and you feel like, uh, you know, kind of spend your time getting beat up by, you know, someone from the sponsor side. So just kind of keeping in mind that, you know, you really just want to improve as you go. I mean, when you get a new protocol, they're all, it's like, they're all new, you know, every time you start a new protocol, it's, there's stuff that you can't know until you just get in there and start doing it. So I think that's great advice, you know, it's great advice for anyone in any point in their career in clinical research is, you know, just focusing on continuing to improve and not being bothered by, you know, the small, small mistakes that get made because it's, I mean, it's just inevitable in what we do.

Kartik: Yeah. And plus it's part of learning. Like I believe that I have learned a lot by making such mistakes and, you know, I still keep learning new things, like, uh, uh, say I'm learning a lot now in my current role also of different things, which I never say even thought about that this something can be done in a, in another way also in I'm still learning.

Brad: Yeah. So you've climbed up and now you're the, what is your title right now?

Kartik: I'm the Research Operations Manager with the Cardiovascular Medicine Department here at University of Kansas.

Brad: So you said that's awesome. So you've taken a, got a whole different role and a whole different kind of perspective than coming from a, you know, as a less of a coordinator and more of an operations manager now.

Kartik: Yes. Yes. It took me some time though.

Brad: Yeah. It's a whole different mess when you're, uh, dealing more with managing staff and dealing with people that aren't your research subjects.

Kartik: Yeah, for sure. For sure. I mean,

Brad: that's awesome. So you were, uh, you're in the cardiology department.

Kartik: Yes.

Brad: Nice. And you came over, I said we worked together at the Heart Hospital and you did a, you worked in quality a little bit there as well.

Kartik: Yes, I did. Uh, I did like internal audits, uh, QA audits and also kind of, uh, uh, helped with, uh, some of the SOP are SOP writing. Like, uh, you know, recently before I left, uh, we, I wrote a couple of SOP actually related to the E- electronic signature in, uh, the E-regulatory system implemented it Heart Hospital. So I worked on that also, uh, worked on the correct, doing pre preventative action plans. A couple of, I wrote a couple of doors during my time at Oklahoma Heart Hospital.

Brad: Sure. Yeah. And again, that's again, to kind of rounds out your experience all across the board there. So are you guys using electronic systems, uh, at the University of Kansas?

Kartik: Uh, so we use a couple of different systems actually in, uh, the way, uh, it's kind of unique system here. I would say, like, you know, we have, uh, uh, uh, RI which is the Research Institute, which you can call a one stop shop for everything. So, uh, they kind of support, uh, all the departments with research and they support you with say the legal, uh, contracting and budgeting, and then the study buildup, and they also kind of manage the study finances and manage the study for you. So, uh, for them, we use a system called, uh, Chris Veloz, uh, which is basically a CTMS. So that is one of the systems we use then for, uh, IRB. We use E-compliance again, that's a electronic IRB system they use, uh, it's pretty similar to irb.net.

Brad: Sure. So is the, is the CTMS like a proprietary thing for the university or is that a commercially available CTO? I don't think I've heard of that one.

Kartik: I believe it's available, but unit's kind of more customized to their needs and requirements. It's mostly managed by, uh, the department here, but I'm pretty sure I've heard that it's kind of available, but I, I never heard before I joined here, like I only knew about the other ones we have used, so

Brad: Sure. no, it's interesting. So you guys have sort of a centralized, uh, sounds like the budget and contracting is centralized through a department there at the university then. Yeah.

Kartik: Uh, yes. It's like, you know, they kind of negotiate for you. So they are saying the middle man, you can say for the departments who do not want, or who do not have, say resources, not every department is say as big as cardiology here, for example, or cancer center. Uh, so some other departments, they may have just one or two coordinators running the show for them. So it makes it easier on their part, uh, when somebody else can negotiate the budget contract and with the bigger system, uh, the legal issues are more prevalent. So, you know, they just want to make sure that we are covered.

Brad: Yeah, no, that makes sense. I, uh, I have to admit that I don't miss having to deal with the bureaucracy of a large institution. So, uh, you know, I'm glad that it seems to work well for you guys there. Uh, it's always been a bit of a mess, uh, whenever I've, I've seen it. So that's, it's good to hear that you guys have a good, it's a good resource for you.

Kartik: Yeah. It's like, you know, just like with everything there are pros and cons for everything. So yes, it is a good resource, but at the same time, sometimes it kind of also slows down your, uh, startup time or things, you know, which you can do in more, a faster way. So sometimes we, we do experience those things also.

Brad: Sure. Yeah. I mean, that's to be expected, I think with any large institution, but nonetheless, it's still, it can be, it's good that it's a resource that's there for the smaller departments or maybe the departments that aren't as experienced in those different facets of the clinical research process.

Kartik: Yes.

Brad: Well, very good. What do you think what's something you've picked up in your career that you consider sort of a best practice or something you would sort of share with the other clinical research community out there?

Kartik: Uh, one thing I learned very early when I started was that, uh, research in research in clinical research, it is very important to have a good documentation practice. So that is something I always follow, like, you know, document every encounter, every thing, whatever the phone conversation you have with the patient and save every emails and all that is one of the things I have picked up. And I still, uh, I still follow that. Like if I'm consenting a patient or if, even if I'm making a phone call to a patient, I usually jot down that our conversation, date and time, uh, of the call in then, uh, whatever was discussed.

Brad: Yeah, no, that's and that's great advice. I mean, it, I can't tell you how many people I talk to on a day to day basis. So trying to remember a conversation or remember when a patient called or when you asked them a question is pretty much impossible. So, uh, do you, do you prefer just to have a blank progress note page, like in the front of your binders?

Kartik: Uh, yeah. So what I did, uh, as a coordinator that I created a progress note template and, uh, L just, uh, it will have a column for say date, and then it will have a bigger column for, to document the notes. And I would pretty much have, uh, uh, that along with the study name and the patient, uh, place for patient ID so that, you know, you can always, uh, put it together in a patient binder, if things get here or there, or if you're late in filing, then you can easily find it, file it with the proper patient charts. So that's what I do

Brad: create a template. And you're ready for any study ready to take a note at any time. Yeah. That's, uh, that's good advice. I'm terrible at that. So I applaud you if you're able to, to keep up with that, that's, uh, something that any coordinator can immediately start implementing if they don't do that. Uh, I imagine that's probably a pretty, fairly common practice, but again, I know that I struggle at making sure that I document every encounter. So that's a good, good advice. Uh, what do you consider to be some tools or resources you use that help you do your job better?

Kartik: Um, I mean, again, given current role, I think one of the best thing is basically I would say, uh, outlook calendar is what keeps me organized and united gets me to my meetings on time. So that is one of the, like the best thing I I'm using currently. But apart from that, like, you know, as a coordinator, I would say that, you know, uh, keeping like, you know, having regular meetings with the PI's and as I said, documentation, and then, uh, one thing I always did as a coordinator before, like, you know, I always involve the physician or the PI before, uh, talking to the patient or presenting the study to the patient in that kind of, you know, gave the patient confidence that, you know, they are signing off signing for something which their doctor also, uh, believes that it will be helpful. And, uh, uh, that also helps, uh, like, you know, uh, enroll with the enrollment and, you know, uh, key, uh, it, it helps, uh, keep up with, uh, recruitment goals actually. So

Brad: yeah, no, that's, that's for sure. Uh, again, another piece of great advice, as much as you can, and it can be more difficult depending on what your setup is, but if you can have the doctor present the study, even if it's not, uh, you know, ridiculously detailed, cause you're going to go through that in the ICF process anyway, but at least if they can, uh, help explain what's involved in this study kind of on the front end. Yeah. They, I mean, truthfully patients listen to their doctors for the most part. Uh, so to hear that coming from their doctor carries a lot more weight coming from, you know, a random study coordinator they've never seen before. So again, that's, that's a great piece of advice. And again, that can be tricky depending on just what your, what your setup is, or if you're a standalone research site that might be, uh, not, it might not carry those same weight as being their, their personal doctor. If they're seeing a specific study doctor, as much as you can. That's, that's always a smart idea. Well, very good. I want again, I want to thank you a lot for coming on. Um, and, uh, I would love to have you back if we want to continue to go down some rabbit holes. Uh, again, I'm hoping this sort of takes off to the point to where we can all share our best practices and just sort of tips with each other. Uh, if anything else worked in people, uh, reach out to you if they want to, they want to talk to Kartik.

Kartik: Uh, they can, uh, they can reach out to me on LinkedIn. I'm on LinkedIn and I'm very active there. I mean, not posting as much as you do Brad, but I do every now and then. And I can also be reached out on my personal email, which is my first name, Kartik.Munshi@gmail.com. So, uh, and again, if somebody needs to talk to me, I'm more than happy to share my, uh, phone number also.

Brad: Very good. And I'll put your contact information in our show notes. Uh, it's available at notetofilepodcast.com and until next time, thank you so much. Kartik

Kartik: you're welcome. Thank you, Brad. Thank you very much. It was nice talking to you.

Speaker 2: All right, guys. Thank you so much for listening. The whole reason I started this podcast is so that clinical research sites have a forum to share information, share best practices, to share tools and resources they use. So please reach out with any questions or comments you might have. I can reach me brad@notetofilepodcast.com. Thanks so much for listening. We'll see you next time.