Episode 07: Jeannie Farnsworth and the Exciting World of Research Compliance
Jeannie has worked in clinical research for 20 years across multiple therapeutic areas including gastroenterology, ophthalmology, neurology and endocrinology. Her experiences range from study coordination, clinical care and conduct, regulatory oversight, site operations, on-boarding and training, and site management. She is currently a Research Compliance Analyst at Banner Health and the Phoenix Chapter Chair for SOCRA.
In this episode we discuss the increasing use of telehealth, training new coordinators, SOCRA vs ACRP, the exciting world of research compliance, why data quality is so important and the importance of asking questions.
Mentioned in this episode:
+ Full Episode Transcript
Brad: Hello, and welcome. Thank you for joining us on the seventh episode of the Note to File podcast. A collection of interviews, best practices, and candid conversations for clinical research sites. Today on the show we're joined by Jeannie Farnsworth. She's worked in clinical research for 20 years now and worked across a multitude of both therapeutic areas, as well as roles, including study coordination, clinical care and conduct regulatory oversight, side operations, onboarding training, as well as site management. She's currently a research compliance analyst with banner health. We had a great conversation today. Uh, everything ranging from the increasing use of telehealth in a post COVID-19 world, uh, talked about training new coordinators, uh, and the difference between SOCRA and ACRP. So without further ado, here's Jeannie Farnsworth. All right, Jeannie, thank you so much for coming on today. I'm kind of asking everybody, how are you holding up in this, uh, you know, post COVID-19 world?
Jeannie: I think that, you know, we're all holding up pretty well, right? It's one of those double edged sword questions you want to ask, how are you doing, but then do you, at that moment in time, have time to listen to the real answer. And so I, I kind of sometimes refrain from asking how people are, but then I think, you know, I think in the very beginning, everyone was super scared. Um, and I think now we're kind of getting used to this new norm and helping each other out and kind of more brave and the problem solving more than ever before. Um, so I think pretty well. I mean, there's more solutions. We have more knowledge now than we did two months ago, so I think that's good.
Brad: Yeah, no, that's a fair point. It's a, I mean, there's still a lot of fear, even at least from a site level, we're still getting patients to come in or enrolling patients in new trials is still presenting a lot of challenges. Uh, we've seen how sponsors are doing their best to come up with different come up with different ways of really just start instituting the already existing technology to help, you know, see patients remotely and things like that, which has been very interesting. Uh, I wish it were a little more well-organized than what I saw from a lot of sponsors. Uh, especially, you know, this is 2020 it's about time, you know, this is, it's both sides of the coin. It's great that, you know, this is driving some innovation at the same time. It's, I mean, it's a little bit sad that it's taking this to create these shifts in an industry that should be on the cutting edge of, of technology. You know,
Jeannie: I know, but sometimes people have to wake up to the fact that they should use it. So I know like with our patients, some of them have been really hesitant about technology because they always had in the back of this mind, that in person was the only way because that's all they knew. And once they got ahold of that ability to have telehealth work for them, now we're going back to, um, do they actually want to come on site again? So I think that's kind of funny. Um, and I know that some of our investigators, um, from friends that I've talked to, they were hesitant about using tele-health platforms, but they found that 80% of the time, it really, they didn't actually need to help hate or see anything of the patient, but it was a lot of it is conversation and checking in with the patient, um, with our protocols. And so, I mean, 80%. So
Brad: I'd be really curious to know too how it changes the dynamic between doctor and patient when you don't have anything else to go off of other than listening, having to listen and listen hard to what the patient's telling you.
Jeannie: Yeah. And I feel like they're just from what I've heard is they seem to be more engaged because they know that when this physician is going to call in and see you, you know, FaceTime or whatever platform they're using their time is dedicated to you. Now they are on the clock still. Um, but they're not as distracted as when they were in the clinic going from room to room. So I thought that was kind of interesting news to hear. Um, so I think I'm, I'm really glad and excited. Like you said, it's, it's unfortunate that something like this had to happen to force people to just do it. Um, but now that people have done it, they're getting comfortable with it. And I think that part is exciting. We can move forward finally in 2020
Brad: indeed. Yeah. And it will be exciting to see where the future keeps keeps taking us. Hopefully this is just the tip of the iceberg and we continue to rely on that technology going forward. So yeah, it's been, it's been interesting. I'm glad to hear most sites I've talked to you are managing pretty well. Uh, we were pretty fortunate. We never had to really shut down per se. Uh, you know, we obviously wanted to keep everyone safe and out of the clinics as much as possible, but, uh, we were able to continue enrollment and some followup visits here and there where we could. Uh, so it's, again, it's been, it's been encouraging to see the clinical research world sort of, uh, all stick together and, uh, keep, keep fighting the good fight.
Jeannie: Yeah, I completely agree. What do you think about all this exposure though? I mean, uh, you know, I've been in the field for almost 20 years now, and I can tell you most of my friends and family have never had a clue what I did before. And with all this media attention, it's been kind of nice that they actually have a better understanding of what I do. It's not just staring at a computer. It's not just about analyzing things. Um, but the, you know, it actually leads to progress. And so I, um, again, it's unfortunate that a pandemic educates the public about what we do, but I think that that's, that's, you know, if you have to look at the silver lining of things, I think that's, that's one to look at for sure.
Brad: Ye ah. We, uh, sometimes we just have to take it where we can get it and, uh, if that's, that's where it comes from, that's good. And I have heard some things about the, the idea that this level of, uh, focus that clinical trials are getting will contribute to increase enrollment numbers as time goes on. Now, people are a little more engaged and educated about what clinical trials are and what they do. So that's really exciting. And hopefully, uh, you know, hopefully we can avoid the, you know, politicalization of the clinical trials that some of this is brought on. Obviously I want to go to, I don't want to get in the weeds with that, but hopefully that doesn't, you know, create an opposite situation where it, uh, people are more afraid, but it seems like it's been, again, a very, uh, positive, uh, frame for clinical trials. So again, very, very interesting times.
Jeannie: Yes, I completely agree. So
Brad: very cool. I'm, I'm very curious. This is something that, uh, just always fun for me and I'll probably say it in every podcast, but, you know, I always say nobody falls in, nobody sets out to work in clinical research, they tend to fall into it. So I'm curious to know a bit about your background and sort of how you first got involved working in clinical research. Can you tell me a little bit about that?
Jeannie: Absolutely. I, you know, that's one of my favorite questions to ask people too, because like you say, no one seeks out clinical research and, um, for me, I had just graduated from college and I had my sights set on some sort of graduate work. And I was the pharmacy technician at a cancer center at Huntsman cancer Institute in Salt Lake City, Utah. And, um, I just, you know, I, one of those weirdos that I, I read all the instructions and the footnotes and, you know, when you bring something home from Ikea, right, I'm opening up the instructions. My husband's already building. Right. So, um, when my boss, um, just kind of started introducing me to protocols, I loved it. I love the footnotes, I love the exceptions. And so, and I would remember them. And so I just remember, um, after many failed attempts at a particular pathway in life, excuse me.
Jeannie: Um, this particular principal investigator said, you know, you're really good at clinical research. I really think you should stay in this field. And, and it was a natural fit because I love the science behind it. I loved the progression of each trial. I love that. Um, where are our patients. Um, they had tried other treatments and other things, and this was another reason to give them hope because it allowed them more opportunities. And so I dove into a master's program and I haven't looked back since, so I, I feel like I'm one of the really lucky ones that fell into it. Didn't really know what it was. Cause you know, that first day you hear all these acronyms and you feel like what planet did I land on? You know? And, and back then, like, you know, the internet was still pretty new, so it's not like I could have just Googled a bunch of acronyms. I just, you just like sit on as many meetings as you can you read through these protocols and you just, you kinda like wing it for the first six months. Right. So like I said, yeah,
Brad: that's, I mean, I think that's a, again sort of a very common story I got when I started clinical research, I had no idea what I was doing for at least six months. Probably more than that. It took me forever to really figure out what's what, and then even longer to really get a feel for the full cycle and everything. And that's involved not just your little snippet or a little window that you see as a clinical research coordinator in the beginning. Uh, so this actually, uh, just a little natural segue. I mean, it looks like you, you do some, uh, instructing for clinical research, fast track. I am, you know, as someone who manages coordinators, I'm always looking for the best way to train and educate coordinators. And unfortunately, well, fortunately, or unfortunately, depending on how you look at it, I don't know that I found a way that's any better than just training somebody on the job as you go. But that obviously has some ridiculous limitations in that it might take them a year to see everything that can happen in a clinical trial. Right. I've been doing it 10 years and I still see stuff that I'm like, well, what is this? What, what, what am I doing here? What do I need to, what do I need to do? So I'm curious to know a little bit about them and your, uh, your affiliation. I've, I've seen clinical research, fast track around. I just don't know much about it.
Jeannie: Okay. Well, clinical research, fast track. Um, I'm really proud of them because what they're doing is they're bringing in new talent. Um, so they're looking at, they have to vet their students, of course. And so they're looking for fit in personality. They're looking for fit in background. Um, and these range from people who have a business major to, you know, foreign medical grads from abroad and they've ended up here. And so they run them through like a month long training and they're teaching them everything that you would ever want to onboard a brand new employee. So I've been wearing your at Brad. You try to train someone and if you're lucky and you're not busy enough, then yes, you can properly train them, but it has to be on the job. Right.
Brad: But when does that happen to you? When are you not busy?
Jeannie: Right? When are you not busy? And so with them, they're looking for passionate people, willing to make a difference, willing to have the attention to detail, to have good communication skills. So, um, for about a year and a half, I was a director for them. Um, prior to that, I was a teacher for them. I've continued to teach for them. I realized how much I missed out on the field. So, um, they're able to bring in new talent and these are bright eyed, very intelligent people who want to make a difference in, um, a healthcare kind of way. So there's a lot of training and education as far as when they're talking to candidates for their program. And, um, you know, prior to this pandemic, there was like a two week internship. So they would do their in person training. They would do some online training to reinforce what they learned.
Jeannie: And then they would go to an internship. And at the internship site, they would be able to apply, you know, all that book theory, but actually put it into practice. And, um, we had a pretty good employment rate because fast track also would help these students get jobs. And, um, I think it was right around 72% of students. Um, and they had to really work hard because as you know, this is such a highly regulated field and it's a field that people don't know about. So they're kind of distrusting of newcomers. Right. Um, but I think in the internship, we kind of opened eyes at sites on how you can properly train someone. And so, um, and I think my curiosity was peaked about fast track because as I was exiting one institution, we got these resumes and one just stood out. And then at our interview, I had no idea she had not actually worked in research, but she knew the lingo.
Jeannie: She knew those acronyms that, you know, we had just talked about and I just kind of thought how in the world does she even know the acronyms when she hasn't really worked in research? And she had mentioned that she had gone through this training. So that's kinda how I got first got connected with them. Um, I'm really big on education and training and to be at my best game. So, um, I've been with SOCRA the minute I was qualified to be certified. I did. So I've been part of them for a long time. So currently I am the Phoenix chapter chair. Um, I really believe in the power of networking and relationships, um, not just for like business, but just, I'm really curious about like, what's happening in cancer. What's happening in dementia, what's happening in neurology. I mean, there's so many cool things that are happening that I can't single handedly do it. All right. So for me, I love our chapter meetings because I am able to talk to old friends, new friends, to hear about what they're doing and what they're learning. And I hear about new diseases. I hear about new ways of implants and different things on how to treat something. So I love this field and I love the ongoing training, um, everywhere you turn, you know, even the technology too.
Brad: Yeah. There's, I mean, there is a almost, almost limitless number of things you can learn about or pursue just within the clinical research field. And that's what drew me to it as well. I mean, you don't, you're not going to do the same thing every day and you don't have to do so. You better not want to, cause you're not going to let me go back. I'm I'm curious to know this is sort of a, you know, just a random personal aside, but SOCRA, SOCRA versus ACRP. Um, when I worked at a university, they had a SOCRA Chapter and I went to it and it was great. It was a lot of people got together. They shared a lot of information. I learned a lot from going to those meetings and from, uh, just networking with those people. Uh, when I left the place I worked at was ACRP there's no, there's no ACRP chapter where I'm at. Um, I don't know. Is there any, as far as you can tell, or is there any distinguishable difference or benefit or philosophical, I guess, to philosophical differences between the two, I've just, I've never, I've never known or are they just the same thing with different acronyms?
Jeannie: You know, I love that you asked that question because, um, you know, I have friends who are either SOCRA or they're ACRP and then this very small group of people who do both. And I think that they have foreheads growing out of themselves. Right. Cause like, why would you do both certifications and maintain all of those credits and things like that? Right. So, um, I guess as plainly, as I can say it, and the kindest way that I can deliver it SOCRA tends to be, um, academically at academic centers. Um, they tend to be not for profit. They tend to be government institutions. Um, ACRP tends to be more pharma and CRO heavy. Um, SOCRA, you know, they recertify every three years, ACRP research justifies every two years. There's a one, one designation for SOCRA. Um, it's the CCRP for professional clinical, you know, certified clinical research professional.
Jeannie: And, uh, ACRP has all these different designations depending on the role that you have. Um, and for me, um, when I got first, when I first got started in this field, my institution was SOCRA. And so, and that's, and SOCRA was kind of born out of oncology need and very FDA focused. And whereas ACRP tends to really relearn ICH-GCP. Um, they've kind of in the last 20 years, you know, converged and merge the two together, of course. Um, and so I can't really say if one's better than the other, but I think that they're right. I think their aims are really the same to train, to educate, um, to certify to network, um, to continue to better this feel in whatever medium that we can. Right. Um, so, you know, I had a friend who I finally asked him, you know, why do you have two certifications?
Jeannie: Cause to me, I just think you have too many heads on, on your body. And he just kinda said, you know, for me in my network, um, I didn't want to exclude to just one niche of government, not for profit academic medical centers, um, or just seclude myself to only pharma and CRO. I wanted to have both of them in my pocket so that I could just have the world at my hand. And I kind of thought that was kind of the best response that allowed me to understand. So for him, you know, he's very career driven as well and wants to do a little bit of everything and I've watched him do that. So I think that's the best way that I can distinguish the two.
Brad: Yeah no, that makes a lot of sense. I just, like I said, I felt like I just sort of arbitrarily left SOCRA and got my certifications from ACRP without really even now understanding why, which is, again, I know it's obviously subjective to say, which is better or worse, but I'm sure they both obviously have their, uh, their perks and they both are aiming towards great things. So certainly this is not a, I'm not trying to put one down over the.
Jeannie: right. So pick one, I guess.
Brad: There you go. Very cool. So where are you at today? Are you at a, your Banner Health?
Jeannie: I am. It is a large hospital institution in Arizona and you know, I've been a coordinator, I've been a manager. Um, I've been kind of like the SMO roles. And then I worked as a CRA for a short amount of time and I really loved, LOVED with all caps that job. Um, but unfortunately, um, our sponsor required us to travel a lot more than, than I could handle. Um, so I, I needed a change, but, um, Banner Health has been right.
Brad: See, I always ask my CRA is when they come through, you know, about some travel, none of, almost, none of them are happy with the amount of amount of traveling that they have to do. I can't blame you. I briefly considered, you know, wanting to go down that road. And I was like, man, I just don't, I can't spend that much time in an airport or on a plane. So I, I don't, uh, you know, I don't blame you there, but it sounds like, uh, you know, you've fallen into a good place with the research compliance.
Jeannie: Yup. Research compliance. I think that's kind of the next big thing, right. As we have more trials on board, um, instead of waiting and, and this isn't a diss on external CRA's , but how can we improve quality at the beginning? Um, internally. And so our institution has a dedicated team to, uh, whether it's training, whether it's the startup, um, maybe a source doc creation and having a really good collection point to mitigate the risks that might be involved, ensuring they have all the supplies that you need. Um, you know, they're pretty short handed and we're kind of a special task force for compliance with this emphasis on research and fortunate for us, we've all had some sort of research background. And so it's been, it's a really fun gig. And right now I get to, uh, be in the oncology, um, seen for banner MD Anderson. So I don't know if you knew that MD Anderson has other branches outside of Houston. Um, but we're one of them. Yeah.
Brad: Well, awesome. So, so does your day to day, I mean, a lot, are you working with coordinators to monitor their work? So as a sort of before, before monitor monitor, is that, would that be fair to say that's kind of what, what it is you do?
Jeannie: Yes. I think that's a very fair assessment. So I would say 80% of my week is, um, working with our coordinators. We have for that particular site. Um, we have these protocol implementation planning meetings. And so we're trying to look before that first patient gets to be seen, um, at every single angle, finance, pharmacy, and fusion, um, everything that we could possibly need, um, anything that could possibly be a problem, we try to resolve it right then and there as a group.
Brad: So that's, that's amazing. That's an amazing concept. Um, and the fact that you have sort of a, uh, looks like you have sort of a diverse group of people weighing in on that, I assume, uh, obviously you're not directly involved with the study itself, which gives you sort of a unique perspective, a outside perspective to see because man, how many times do you take on a protocol? And you're like, great, this looks amazing. We're going to kill it. And then, you know, things take off and you're like, Whoa, wait a minute. This is way harder. There's a way more logistical hurdles. We have to jump through. There's a billing problem. There's we need to be invoicing for this. This is all these things that are very difficult, I think, depending on your role, but even, even not, they're still difficult to sort of anticipate. So having a process like that is invaluable,
Jeannie: it really is. And I love that we work together as a team. And, um, you know, sometimes when you hear that compliance is going to be around, some people start running the other way.
Brad: Well, that was my other question is how well, how well received are you by, you know, your normal clinical research coordinator? Because I mean, Hey, and to be Frank, I might do the same thing. I'd be like, Oh God, I got to talk to compliance. Now, come on, man. Let's do this thing.
Jeannie: They never find anything good. Right. So.
Brad: you're not there to, you're not there to Pat him on the back.
Jeannie: Right. And I think that's, that's the thing though. I mean, um, I'm just that kind of person, as much as I might find, quote, unquote wrong. Um, I think I, I want to find all the good things that our coordinators are doing. Um, and so as much as I might give them feedback on findings, I want to give them feedback on what they're doing. Great and ask for permission to, to share some of those techniques or processes that they've implemented with other teams, because we're such a large institution, you'd be surprised how one group will do one thing and a different group in the same department is doing it completely different, right?
Brad: Yep. Nope. I've experienced the same thing and, and academic institutions where, and that's where it's, SOCRA meetings were useful for me is to be like, what do you guys do? You wait a minute? That's completely different than what we do. That's so weird. But to go back, I think that's, you know, obviously a huge point of value for you and for the institution that you can take. You're going to see the whole breadth of, you know, departments and different things that happen. So you can take that those good practices and share them, roll them out, uh, sort of, uh, institutionalize them, you know? So that, that makes it again a really big value of what you can bring to the table.
Jeannie: Yeah. And I think that's how we're building our SOP so that they can be better streamlined and people can learn from the best practices. Right. So as you know, SOP, aren't typically static at any given time and place. So, um, especially, you know, in the last couple of months we've had to tweak and revise and, um, as we move forward into the future, we're trying to figure out how do we best Institute a SOP that will help our staff of course, but also help our subjects and, and their families. So, um, I, you know, I would say most of our staff receives this pretty well. And, um, we do as much training as, as they'll have, they'll give us time for, and it's one of those things. It's, it's a growing process to, you know, sometimes people are very, um, protective of what they're doing and they've been doing it for so long. So to be told that it might not be the best way or, or to introduce a different way. Right. But when you're forced into that situation, sometimes I had one coordinator tell me, um, she had like, I mean, we, we kind of scale things on a percentage and she had like one little finding and it was in the regard of good documentation practices. I mean, amazing coordinator, tons of experience. And, um, and she just said, why did you cite me on that? And I just said, if I didn't cite you on it, then you wouldn't learn from it. And then she said, you're, you're actually really right. Because ever since he pointed that out to me, I don't make that mistake ever again. And I was just like, well, that's, that's why I'm here.
Brad: No, that's exactly what it's all about. I mean, it's a, you know, wherever you can get that feedback to get better at what you do is it's, it's valuable, you know?
Jeannie: Yep. And why, and why do we want better work? You know? And I always go back to this with my family when I think about, you know, why do I want to expedite research? Why do I want to use technology? Why do I want everyone to be trained? Because I know that every one of us will be sick with something in the future. Maybe not. Right. Wouldn't it be nice to have that treatment available rather than it being held up because of bad quality because of unusable data. Um, that's why we all do it, right.
Brad: Yeah. And well, and to know that the drugs, devices and procedures that, you know, maybe use on us later were conducted, the trials were conducted with the high quality and the data was , you know, reliable. Exactly, exactly. So, yeah, no, that's, that's awesome. That's a fair point. So are there any, uh, tips, tricks tools, what are, what are some things that you use, uh, that you think might otherwise help the clinical research community?
Jeannie: Um, so I think as a coordinator for me, one common founding ,finding that I would have as a coordinator, as a CRA and even in compliance right now is, you know, we're all pretty good about training and maintaining our training documents. Um, but the thing that I see is calibration. So calibration of your equipment, um, and it sounds so silly, you know, your scale, you know, when there's nothing on it, does it read zero pounds and when you convert it and you hit that button, does it say zero kilograms? Um, I monitor a site where for whatever reason, the calculation in the scale converted the pounds to the kilograms incorrectly. And they were dosing patients, um, at a, at a slightly diluted concentration for their infusion. Right. And it never occurred to them that they should calibrate the scale. Right. Um, but I've seen this in all sorts of equipment. And so that's one tip that I've given to people twice a year. Most States observed daylight savings time. You know, you have to readjust that clock. Why don't you also do some sort of a calibration? So whether that's at the end of the day, right. At the end of the day, right before daylight savings or the first thing that you do when you get back from daylight savings, starting.
Brad: Sure. I like the idea of kind of building in that trigger to remind yourself to something that needs to be done. I mean, and you know, really all your equipment needs to be calibrated annually. Anyway, you can, you could put it right in with the, you know, the rest of your stuff. That's going to get a, get a nice green or yellow sticker on it. So,
Jeannie: yeah. Yeah, absolutely. And then I think the other one, um, is I think sometimes when, especially people who are getting started, I think that's the best opportunity to, you know, whether you're a new employee or new to research, um, ask questions, you know, find a mentor. I think so many of us are so willing to share of our knowledge. Um, but I've noticed that sometimes people are afraid to ask and, um, so they end up just doing it on their own and they're flying solo. And
Brad: sure. A lot of that I think maybe goes back to, you know, the environment that you're in. So, you know, I started out in a academic department where there was a very aggressive, uh, chair for the department and he would like to come in and basically ask coordinators questions that they couldn't possibly know the answer to, to try to trip them up. And, you know, as a result of just created this environment of fear. And so people, you know, you didn't want to ask a question in fear of looking ignorant or something like that. So, you know, that, I agree with you a hundred percent. I can also understand why, especially in some, I dunno, higher pressure, I don't know if pressure is the word, but in some academic, especially institutions that were just, I've noticed that there's this a very strong hierarchy and, uh, it can be trickier for people who maybe don't have the confidence to do that, but absolutely you're right. I would recommend a hundred percent do that. Even if it's uncomfortable at first, you're going to end off end up better off at the end of the day, if you are, if you're able to follow through with that.
Jeannie: Yeah. So I think for those people, I would say, you know, you know, pay attention to see who you could ask questions for. Cause obviously you do want to be careful who you ask those questions. And, um, but I guess my, my point in that is when you're asking those questions, I think the best opportunities that, you know, say at a new job versus three months later, when you probably should know the answers to those questions,
Brad: thank you so much for coming on today. I was very, uh, enlightening chat. Uh, where can people find you online?
Jeannie: Uh, LinkedIn is probably the best way to get ahold of me. Um, I'm always excited to meet new people and like I said, see what they're doing and how they're doing it and, um, how they failed in it because we all learn from that. How however humbling that is. But, you know, I love it. This is one of the best fields I believe, um, that exists because it does, um, have limitless opportunities, you know, technology, data management. I mean, there's so much in research, so I appreciate your time.
Brad: No, thank you. And I couldn't agree more. I will post your contact information in the show notes and ah again, thank you so much for coming on.
Jeannie: Yeah of course! thanks.
New Speaker: Thank you so much for listening to the Note to File podcast for guests contact information, as well as any resources mentioned throughout this episode, please check out the show notes at www.notetofilepodcast.com. If you have any questions, comments, or interview requests, please feel free to reach out to me. I'm Brad@NoteToFilepodcast.com. And once again, thank you for listening.