Episode 26: Tiffany Ashton, ClinEssentials
Tiffany Ashton has been in the clinical research industry for over 18 years, holding positions such as Clinical Research Coordinator, Clinical Research Associate, and Clinical Trial Manager. She has gained both Sponsor and CRO experience in various indications including Oncology, Gene Therapy and Rare Disease. In her current role as Director of Operations with ClinEssentials, Tiffany works with a team of clinical research professionals who strive to help the industry save time and stay organized by providing pre-printed audit documentation that replaces the standard yellow sticky notes currently used in monitoring.
In this episode we discuss tips for making the jump from CRC to CRA, the importance of relationship building and leveraging your network, and the significance of continual development and reflection throughout ones career in clinical research.
+Full Episode Transcript
Brad: All right, Tiffany, thanks so much for coming on today. I really appreciate it.
Tiffany: No problem, Brad. Thanks for having me.
Brad: Yeah. So I was originally drawn to a post you put on LinkedIn that was talking about sort of all the different ways people come to clinical research. And you know, the first question I always lead with. With all of my guests is tell me how you got into clinical research in the first place. I think it's an awesome question. It opens up all kinds of different perspectives on, you know, how people enter the industry, why they enter the industry and kind of how they end up where they are. So tell us a little bit about your journey or how you started out.
Tiffany: Perfect. Yeah. Um, so as you said, everyone is different. I don't think I've ran into one person that has had the same entry point into the industry. And, you know, when I graduated high school, I was in Los Angeles and had moved to San Diego for schooling. So I was attending San Diego state university, and I was looking for my first part-time job and I applied for an admin assistant position at a site management organization. And at that time I didn't know what a site management organization was and when they had, let me know, you know, we do clinical research trials. I was like, I didn't even know clinical research trials were even a thing or this whole industry even existed. Um, so I was, I was very curious just from that initial, you know, we do clinical trials to help pharmaceutical companies bring drugs to market. And I said, "wow". And so, you know, as an admin with the SMO, I just got in and just kind of observed, you know, I, I observed the day-to-day life of the clinical research coordinators and what our SMO did. We had a main office and then we would go, uh, well, the CRCs would travel to different doctors within the community and they would have like a research office at that doctor's practice. So the doctors were adding research to their practice, not necessarily research only, but just incorporating the two. And so I sat at the main office and I would watch them, you know, get ready for their visit to the doctor's office and, you know, put all of their lab kits and their binders and, you know, all of the things that they needed to see their patients. And so I just observed that and I was like, wow, I would love to do something like that. And so I spoke to the clinical director and I said, you know, this is something that I would be interested in. Is it something that I can learn maybe shadow or kind of on the job training? Is that something that you would be willing to teach me and the clinical director, she was great. She ended up being my mentor in just getting into the industry, but she said, I think you would be actually a really good study coordinator. And so just that simple conversation kind of opened the door to me becoming a study coordinator with that SMO. And we basically, what I did was I took, um, I think it was two courses on like medical, like medical terminology, because at this time I was still doing my undergrad at San Diego state. So I was in college courses, but I took two medical terminology courses just to make sure that I knew the medical lingo. I also sat in on, you know, site initiation visits that were being conducted or the various doctors I sat in on site selection visits as well. And, you know, I saw some of that. I sat in on inter monitoring visits, also site, uh, close out visits, attended trainings, you know, so they slowly started adding me to the site training and site delegation logs across their studies. And I just sat and just kind of observed, you know, I didn't touch anything. And I shadowed at about maybe six weeks of just kind of observing and taking my medical course. I shadow, I start shadowing like the day-to-day of a study coordinator. And I did that for about three months of shadowing. So about like, uh, about four and a half months of just kind of observing shadowing before they said, okay, we have a new study that starting, how about you take this? And you lead this one study and the rest was history. That was my start. That was my start in the industry.
Brad: I love that because I think even now I still see so many people sort of look down on the idea of somebody getting into clinical research, um, you know, on the site level who don't have some sort of specific medical or clinical experience. Um, and I think that, you know, your path speaks to the point that, you know, if you have solid soft skills, then you can learn medical terminology, you can learn how to follow a protocol. You can learn how to collect data with high quality. Uh, so I, I love that because again, that's, I know when I look for coordinators, I'm looking for people who have great characteristics and not necessarily what their clinical background may be. Of course, that can be helpful, but, you know, I love, I love hearing that you sort of, you know, again, went from admin to, to clinical research coordinator. I mean, that's, that's awesome. I love that.
Tiffany: Yeah. And, you know, because of how we were set up, we would go to travel from the main office to the various doctor's offices and that doctor had their own medical practice. So we would have the phlebotomist there, you know, we would have a medical assistant that could do the ECG, you know, so I didn't have to get into the nitty gritty of medical, um, per se, because we had a team that I can say, okay, uh, can you draw this blood? Or can you do this, um, uh, this ECG for me and go, you know, and I was doing, you know, more of the protocol specific items. And over the years I learned, you know, additional medical terminologies, how to read a medical chart, you know, the PI and the sub-I. They gave me a lot of guidance, but it was really about taking someone, taking a chance and seeing those soft skills, like you mentioned, Brad, and being willing to put in a little bit of time and look at me now, 18 years in the industry, I went on to get a master's in clinical research and, um, I've run global trials of phase one through four and all indications, oncology, oncology, gene therapy, and rare disease. And it all stems back to, you know, that clinical director seeing something in me and me having that drive and you can do it. And so, you know, I, I want to encourage those that are looking to get into the industry, um, that have a desire to be a coordinator or even a CRA or a CTM to go ahead and, um, you know, start there, start at the site level. You know, you can start as an admin assistant express that you're interested in, you know, maybe learning other roles and then take the opportunity when they say when maybe a study coordinator is over overworked or, you know, doesn't have enough time, you say, Hey, can you teach me how to do that? Maybe I can do that for you. And you start getting those skills and the slowly, when they see you at, in that manner, they're saying you can definitely be a study coordinator and, you know, the practices already. So it's a no brainer for us, let's bring you on.
Brad: Right. Right. Yeah. And to two things about that strike me. One is that, you know, just by being, you know, in the proximity of the things that are going on, again, you could've picked up phlebotomy skills along the way. You could have continued to pick up, you know, more clinical skills, but I mean to win, you gotta be in the game and you, you were, and that took coming in as an admin assistant. And, you know, the second part that strikes me, that ties into that is that it took time. And, you know, I've noticed that it takes a long time to be a good coordinator, I think because you don't really have to have, you have to be exposed to so many things before you understand how it sort of all fits together to the bigger picture. And, you know, unfortunately you just don't, it doesn't happen quickly. It happens in sort of these little, little snippets, and then eventually you put it all together and you're able to sort of see the bigger picture and say, oh, I really get it now. But again, it goes, it all goes back to, I mean, you raising your hand up and saying, you know, I want to do this. Can I, how can I get involved? And again, I think that's, uh, that's awesome. So where did you go from, from there? How long did you do that and where did you go from there?
Tiffany: So when I graduated from San Diego state university, at that point, I had four years of coordinating experience. And, you know, I knew that I was interested probably at year three of being a study coordinator that I was interested in being a CRA, because I was intrigued by the travel, seeing new sites and working with new doctors all the time, maybe being on different protocols. So being a CRA excited me. And so I was given the opportunity right after literally it was like almost the day I graduated. There was a, there was an opening that they were looking for experienced coordinators to almost do like a hybrid CRA slash CRC role. And the reason why I say it was hybrid, it was, it was because it was a phase four study and it was a medical device study. And the FDA had asked that this particular company track 60,000 women who had gotten breast implants in a long-term observational study. So it was a unique study because 60,000 that's a lot, you know, I, I've never been on the study that you have 60,000 of anything. It's usually a thousand, 2000, maybe 3000 patients across the study. So 60,000 women were being tracked and their outcome of their breast implant surgery for 15 years. And what made it unique was we had to work with plastic surgeons and plastic surgeons. Most of them don't know about research. And so, and they could care less about research because, you know, they're in their whole world of plastic surgery and making the big bucks there. And this was almost like a mandate on them to enroll a certain portion of their breast implant surgeries into the study. Otherwise the device could potentially be pulled off the market if the FDA didn't get their data. So the reason why it was a hybrid study is because I had to go in for some of these plastic surgeon sites, I had to help their nurse or their main patient coordinator, how to, I had to teach them how to consent. And for some of their patients, I consented them. So I was like a study coordinator, but for other sites, I was more so of a monitor because I was just monitoring that the consent was done correctly. So that's why I said it was like a hybrid position because it wasn't anything that I had seen up to that point. And honestly, this is nothing that I've seen since, because it was a special, unique medical device study. Um, and the numbers were such a big number, 60,000. And we had like research naive to the T with plastic surgeons that really didn't know anything about research. That was an interesting, it was really interesting, but I really enjoyed it because it was almost like a stepping stone into CRA world. It wasn't full on. I had to do from A to Z. I was maybe doing A to D on CRA, but then I also was able to use some of my CRC skills of, Hey, this is how you properly consent. These are the records that we need to keep, you know, and helping them get processes in place in order to, to conduct the study. And then also following up with the patients that were enrolled to do their, their questionnaires that they had to do on a certain, I think it was like every six months basis. Um, so I was in that role, it was a contract role actually. And they kept extending my contracts for a year. And I ended up being in that contract role for three and a half years in total. Um, and at that point we had enrolled all 60,000 women and they could take over the maintenance and the, you know, sending out the questionnaires to them every six months now that they weren't enrolled in the trial. So that was my first kind of exposure to the CRA world. And then that was my first exposure to the contract world as well, to be a contractor versus a permanent employee.
Brad: So what kind of, I mean, and I see it all the time. I personally never had an interest in, you know, doing any CRA work, but we, you know, we see it a lot, people are interested in how to do it and they seem to have, you know, troubles bridging that gap, uh, between site level or site level experience and, and becoming a CRA. So, I mean, what sort of insight do you have that, you know, you might tell people to give them a little bit more of a leg up in that journey.
Tiffany: Yeah. So, great question, Brad. So right now in the industry, the industry is smoking hot. When I tell you we're smoking hot right now, it's smoking. This is if you're trying to get in and bridge that gap, this is the time right now. And we go through these waves and seasons, and you've probably seen it too, Brad, where it's like, we have too many studies and not enough help. And then we have too many people, but not enough studies, but right now we have too many studies and not enough help. And especially these big CROs you know, the IQVs is the icons, the par Xcel's, those big CROs. They are always taking on big studies and maybe multiple years studies and multiple drugs coming in a portfolio from the big pharma companies. Sometimes they bite off a little bit more than they can chew and they don't have enough. They don't have enough people and they've already signed on in that alive. Um, so the reason why I say that is right now, you want to go, if you're a study coordinator and you're looking to become a CRA go and look and keep your eye out, indeed.com is a, is a good one. Um, where you go on, I N D E E D.com and you can go on and you can type in clinical research associate. And then you want to look for entry level, or CRA one. You want to look for the qualifications at that level when there's too much demand and not enough staff when those qualifications kind of change. So right now, what I've seen is that they're willing to take a senior study coordinator or a study coordinator with two or three years, our study coordinator with one year, depending on the company. And they will train them, give them on the drop CRA training. Now is the time to look for that because the industry is hot. You know, now maybe 12 months, 18 months, two years from now, the industry, there's not as much demand. There's not that many studies. And then, you know, they don't meet as many people. And then at that time they may even change the criteria for a clinical research associate one to be, you got to have one year monitoring experience, so they may switch it. But right now, because there's such a need, it's like, come one, come all. If you're coming with something and you know about research and you are being a study coordinator, 2, 3, 4 years, we can use you because we can bridge that gap with our SOPs and our structure and our onboarding. So this is the time like if you're really interested, that's one way, look for openings. Look for, um, I know med pace is a CRO and they have a CRA training program. And I think icon has up CRA bridge program. And those are basically where they are going to teach you how to be a CRA. And they would love for you to becoming if you're a study coordinator, perfect. Cause you have two, three years and you understand at least the basics of what a monitor usually looks for. And so they can bridge that gap. So that's why it's called like a bridge program because they can bridge that gap of where you're coming and where you should be as a CRA and help support you. Um, so that's one avenue of kind of, if a CRC is looking to be a CRA that's one avenue to get in.
Brad: Strike while the iron's hot.
Tiffany: Yes, strike while the iron's hot and it's hot right now. And it's because of COVID, COVID release such an influx of new studies in the industry. But what we have to realize is we still had all the other drugs that were in the pipeline for oncology and where disease and cardiovascular obesity, those still were in the pipeline for the various pharmaceutical companies. They just got put on the back burner because COVID is in the spotlight right now. So then it came all these COVID studies, but we still have those other studies that have been on the back burner. So that's why there's a need even more so than 2019 is because we're we had COVID happened. So it was almost like the perfect storm, you know, not necessarily COVID was a good thing, but for those looking for opportunities, the opportunities are now because of, there's just an influx of new studies right now going on in the industry, plus the old.
Brad: Yeah, no that makes perfect sense.
Tiffany: Yeah. And so that's, so that's one way, you know, looking for entry-level positions for companies. Another way is if you're a CRC, you have 1, 2, 3, maybe 10 up to 10 CRA's that you're interacting with at one point in time, one point in time you're interacting with those CRA's whether it's via phone, via email, via, um, them coming on site for monitoring visits, establish a good rapport with those CRA's the CRAs can be your friends. You know, like I know sometimes it's like, uh, some, some of the dynamic relationships, it's not so friendly between CRAs and CRC, but ideally everyone should work together. And I know as a CRA you acknowledge and you see, and you know, who's a good study coordinator and you, you keep that person in the back of your mind. Hey, if I see something come across my email that we're looking for new CRA's you have any referrals, I'm going to keep that lovely CRC in mind when I see that email. So get friendly with your CRAs, but be genuine too. You know, you don't want to come off that you're just using them to get in, but, you know, establish a good relationship. Good rapport, good communication. Because when a CRA is at a CRO and they say, Hey, do you guys know anyone in your network? And they see the criteria they can say, oh yeah, I do know a study coordinator since they're taking study coordinators. Yeah, I do. I can send over that, this person's name and then, because the CRA's already in the CRM, they can even put an extra, oh, yes. She's great with communication, you know? Oh, he's, he's excellent with the organization. He's very timely. You know, he would be a perfect CRA. And so that's why it's really good to have those good relationships with your CRAs when you're able to, when you're on the site level as a coordinator. So that's another way in, and especially now that the CROs are hiring, like, like how cause hiring hire, they are, I guarantee you, they are sending out mass emails to all of their current staff. Do you know anybody that you can refer for these openings? Um, and so that's another way in, by speaking and just being friendly with your, your CRA.
Brad: Yeah. And while I think that's, it's always a good idea, I think to, you know, create good relationships and network, but just like that, I mean, I think, you know, create a good relationship with your CRA show them, you do good work, be responsive to them. And then when these opportunities come around, it becomes that much easier to say, Hey, I know there's a lot of hiring going on. What do you know, what do you know about what's going on out there? You know, you know what saying available? So it's a, Hey, it's just a good idea, you know, to always have a strong network, but then you can really leverage that when the time comes. So yeah, those two things fit together beautifully. And I think a lot of times people overlook that face to face relationship. I mean, we do so much talking to people on LinkedIn and social media and networking, but sometimes we forget about the people we're actually working with who know us best, who we can be able to have help us out along the way. So now I love that. I think those are two really solid pieces of advice for people out there looking to make the jump from CRC to CRA
Tiffany: Yeah. The, you know, whenever we do get back to the conferences, the industry conferences, that's another way to go to the booth of a CRO or to a pharmaceutical company and just express, you know, your interests. You know, if your study coordinator and you go to a SOCRA conference or an ACRP conference, that's another way to have a good conversation face to face interaction, show that person that, Hey, you know, this may be someone we want to have on our team. And that also goes a long way. So you know, all of these items and, uh, to go back to my last point, brat, you know, even if a CRA almost like a recruits in, you know, a study coordinator that they've worked with that study coordinator can leverage that CRA who's already in the company. And once they get on board, they can use them to say, Hey, can you show me the ropes? Can you show me how this system works? Can you show. me? And so it almost becomes nowaday. They almost take you under their wing to assess as a mentor. And so that is even better than what you probably originally had thought. Now you have a mentor in the company that could show you the culture and the, and how things are done so that, you know, that's another second layer to just networking and having a good rapport with your CRS, because it can take you far, it can get you where you need and they can give you the support when you get there.
Brad: Yeah. And that, that's just, it, it's not these aren't transactional relationships. These are personal relationships, you know, that do benefit both people over the longterm. So yeah, just like that's perfect. Do you have a built-in mentor perhaps, and you know, you both help each other, you know, continue to grow your careers. So I love that. I think that's a very, uh, kind of a nuance thing. A lot of people don't think about. So I think that's awesome. Piece of advice again. So after you jumped, after you had your CRA slash CRC sort of hybrid role, what was your, what was your next step in your journey?
Tiffany: So the next step I actually wanted to get and was curious about the project management, you know, what is project management like a project manager slash CT, um, clinical trial manager, you know, every company has a different term for terminology for it, but it's project management, it's clinical trial management, it's oversight of the entire trial and being responsible for the clinical delivery. And, you know, I had a curiosity in that. I don't know why I went from CRA and just jumped to, Hey, let me manage this whole thing. But, you know, I was curious, you know, yeah. So I was curious, so I actually applied, um, at a small biotech company about a small biotech company in San Diego, because I was still in San Diego at that time and biotechs and small pharmaceutical companies. That's another hidden Jewel that people may not realize there's opportunity there. And the reason being, I didn't have project management experience at that time, up to that point, I just had, you know, CRC and CRA experience. And I didn't have project management experience, but because they were a small biotech company, a small pharmaceutical company are also another examples. They had a clinical development department, it was small, it was like 16 people. And they originally brought me on as like a CRA and within like three months, there was a need for a project manager on a phase four observational studies for like IBS. And so again, got in as a CRA showed that I was interested in that project management and was offered the opportunity because I was close. I understood the processes and I had the soft skills to, you know, with the little guidance of following another senior CTM or senior project manager was able to understand like, okay, all right. So this is how, you know, we negotiate investigator budgets, and this is how we work with data management to create the EDC database. And this is how we work with the medical writers to create the protocol. And at that time, because I have had it CRC experience and CRA experience, I was able to really help with some of the protocol development because what the scientists think. And they, you know, they, they dream up in a, in a protocol in actuality, we know that whew, you know, we really can't keep these patients here 12 hours like---
Brad: not always practical.
Tiffany: Exactly. And so I was able to say, you know, let you know, I was able to use my study coordinator experience to say, Hey, what about this? You know, we can get the same result, but it would be less pressure on the site, less pressure on the patient, more likely to be successful and have them complete if we tweak this. So, you know, never be afraid to kind of use your experience. If you see something in that protocol development stage, that's the time to speak up and say, Hey, I don't think, you know, having a fast at 12 hour fasting, uh, visit that would kind of fall at 7:00 PM is practical. Maybe we need to, you know, do something different here. That's the time that you can kind of share some of that real-world experience when they're developing the protocol. Because a lot of times they'll scientists and the medical writers they're so high up, they've never been at the clinic level. And to bring that, they're like, oh, I didn't ever realize that this would be a complicated day or a long day or something that a study coordinator or a PI would have problems actually implementing without a lot of protocol deviations. So, you know, I, my skillset up to that point was very valuable. And, um, and I enjoyed the experience. I enjoyed learning on the job, how to be a project manager, how to negotiate, budgets, how to find vendors, how to do vendor management of your IRB, how to do vendor management of your lab, vendor, and all of those things. So I saw one level as study coordinator as a CRA, but it was a whole totally different, not beast, but it was a whole totally different perspective to see it from the start. Like, how do we set up these lab kits in the beginning? And so knowing how the end result was at the clinic helped me with the planning from the project management position. Yeah. So it was really cool. It was really, I enjoyed it. I got, I learned a lot. And the thing about it is, you know, along the way, you always want to be learning, observe, pick up a tip or two, you know, that adds to, so when you go to the next job, you know, something for, oh yeah. I know how to negotiate budgets. That's something you can use in your interview because you had some experience, you had some exposure. Yes. Every company is different with their processes, but at least, you know, the overarching premise of, okay, I know how I was. I did it before. If even if the process is different here, at least I know the basics of what we're looking to get. And so I just took that. And then from there, I really wanted to get CRO experience because I was kind of hearing that CRO, you know, that was the CROs were getting bigger and bigger. And I was like, Ooh, what's going on in the CRO world. So I went from small pharma from that biotech into a fairly big size CRO. And I stayed there and when I was hired, I was hired as a unblinded CRA, and that was new, you know, to get that unblinded, CRA experience. And not a lot of people get that as well. So good. You know, just dealing with drug and, and, you know, uh, looking to make sure the dosing was given correctly. That was fun learning. Um, the unblinded side of the, the CRA, uh, position. And then at the same time, they gave me an opportunity to be a lead CRA. And so I was split on two studies. I was an unblinded CRA, and then I was also a lead CRA. And so that was my exposure that lead CRA was continued exposure of like leading a team. And also it was like I worked right alongside the clinical trial manager, which was the title there at that CRO. So again, kind of just getting absorbing as much as you can, along the way the lead CRA I manage all of the CRA's under me. Like I was, I didn't travel, but if they were traveling and they had an escalation point, I was their escalation point. And then I also like was one sponsor calls. And I worked very closely with the CTM and the other departments for project planning and just making sure our study stayed on time. And we met in term locks and database locks and all those things. So that was another exposure of like that lead CRA, uh, there. And so I liked the loot CRA position. And then I would say over the last one, that probably for the last 10 years, I've just been in the clinical trial manager space prior to becoming the director of operations at Clinessentials. So, you know, the clinical trial managers space, you know, I took my, my first project management exposure at the biotech. Then I coupled that with my lead CRA exposure at the CRO. And even at that CRO, after about a year of being a lead CRA, I was promoted to CTO and I've been, you know, I, I spent the next portion of my time in the CTM. And sometimes I would do like a, a CRA contract, but CTM was where I stayed before I became the director of operations at clinessentials.
Brad: So it sounds like a little bit of a theme at least throughout your career, as far as sort of getting your foot in the door and maybe not the ultimate position that you wanted to end up in, or definitely not the one that you did end up in, but all along the way, absorbing as much information and experience as you can, recognizing what's, what's transferrable to the next step. And again, just by virtue of being there and present and good at what you do, you're able to accumulate, you know, more experience, more responsibility, kind of each step along the way. So all of this goes back to you being an admin assistant at an SMO
Tiffany: At a SMO admin assistant at a SMO. But if you have the drive and, you know, soft skills and you speak to your manager, speak to whoever you report to, and just let them know, Hey, this is what I would like to do ultimately are on the path to be. And sometimes you may not know what you're on the path to be, but just say, Hey, I'm, I'm open and willing to learn other items outside of my role. Just saying that opens up so many opportunities for you. And then literally there's only like regulatory. I haven't did as much regulatory in the sense of like submissions to the FDA. And, you know, I, I didn't, I never got the, the experience in that level, but I do have at least the basics of how to do the FDA submissions and the IND you know, starting that application, that, that skillset, I never touched in depth, but there's all the other areas I can rock it because I, you know, I've touched it in some point along the way.
Brad: Well, and that's the, that's the beauty, I think of what your journey shows and what I tell people about clinical research is that, I mean, whatever your interest is, there's something in clinical research for you. And so again, seeing how you've progressed through, you know, your career, I mean, you could have gone any number of directions. It sounds like based off of whatever you wanted to pursue, because again, you were, you were there, you were accumulating all the experience, accumulating knowledge, just being again, being in the game. I mean, I think that's, that's what, what it takes, but again, you were able to leverage that into the direction you wanted it to go, but it could have gone 15 different ways. And again, I think that's, that's the beauty of what we do, I think is that, you know, it's, you can find something that you're passionate about within clinical research, just, just about whatever it may be. You can, you can find it.
Tiffany: Yeah, Exactly. Yeah. I could have went the data management pathway and you can be in, in data management and you can be a data manager, like a work in that department. You can do analysis of like all of the lab samples and you can be like in the lab area, you can be in finance, you can be like a contract specialist and helping to put the study budgets together. There's, there's literally, like you said, Brad, there's a million ways that you can go and your experience level and your interest. If you see an area, just continue to foster that, ask questions, Hey, how'd you get in this? How could I, you know, eventually get into this and people will share their story, you know, the nice, friendly ones that are, you know, they'll share their story and then you can say, Hey, I can, uh, maybe yeah, that's something I can look into. You know, that's something that I can look into along the way. So there's, there's so many opportunities. And even if you just sat on indeed and just put in clinical research and you see all kinds of titles that come up and you're like, oh, let me click in here and see what they do. Oh, let me go over here and click this one. And, you know, like you could find a whole new world of opportunity just by just clicking around to say, oh yeah, actually this one sounds really good. You know, this one, this sounds like something I would be interested in.
Brad: Well, the industry is changing so quickly. You might even be, might even be able to make up your own path, but you know, there's things out there we haven't figured out yet.
Tiffany: Exactly. Yeah. There is. There's a lot of opportunity. There's a lot of, you know, there's a lot of opportunity. There's a lot of process improvements, um, that could be made in the industry even to this day, even though we have so much going on. So there's a lot of whatever tickles your fancy, you can find it and you can probably improve on a process, you know, in the industry.
Brad: Sure. So tell me a little bit about what you're doing now with, with Clinessentials. I know that we'd like to have you back and do a more focused episode, but tell us just a little bit about, uh, what you're doing there.
Tiffany: Yeah. So I'm currently the director of operations and I work with a team of clinical research professionals. And our goal is really to help the industry save time and stay organized. Um, by providing, we have preprinted audit notes, which are called our CRA audit notes and they replaced the standard yellow sticky notes that the study coordinators typically see after a monitoring visit and that the monitors typically place when they are monitoring. So when the monitor is flagging actions, you know, maybe something that, um, doesn't correlate to between the source and the ECRF or something missing from the regulatory binders right now, the status quo is for them to use yellow, sticky notes, blank, yellow, sticky notes. And it's good. It's easy, it's convenient. But at the receiving side for the study coordinators, when they come back after a monitoring visit, and maybe they had 20 patients enrolled and they see a sea of yellow sticky notes, it's like overwhelming. It's like, where do I even begin? Where, where do I prioritize my time? And so the clinic essentials, CRA audit notes, they're color coded. And pre-print it with some of our industry catchphrases, like, please clarify, please file serious adverse event, concomitant medication, please complete. And there's a couple of check boxes that you can fill in what's needed like a initials or a page number or a signature as a late entry, et cetera. So it saves the CRC- uh CRA time when going through multiple patients' charts, because things are color coded and they're preprinted. So instead of having to write, please complete across multiple charts, they just pull that. Please complete note, check off what they need, place it and go on to the next one. And then for the study coordinator, and also for the PI, when they come in at the end of the visit, they can quickly see what needs to be action. And if there's any trends for retraining, um, if they see 15 protocol deviations, color-coded with the red bar, it's like, well, okay, we got a lot of protocol deviations. We need to, what do we need? What do we need to retrain on here? Are we got a lot of serious adverse events what's going on over here? You know, like, so it's a, it's a quick method for, if you just needed to come in and see, how are we doing? You can quickly tell by the colors. And then we have a pocket reference guide that for the PI and the study coordinator, they put that pocket reference guide in their pocket. So when they need to reference a color, oh, that's yellow. Oh, that's please clarify. Okay, I'll get to that. Or, oh, this one, please report to the IRB. Okay. Let me get to that one first. So it just really helps with the prioritization and the communication. It streamlines it, and it cuts down the action item, close your time. Oh man. Some of the coordinators, they say it increases their action. Action item closure time by 25%, others say 50% because they can quickly see what they need to look at now versus what they can come back tomorrow, the next week or prior to the next visit to, to action. And the CRA's benefit, less writing for them, more streamlined communication, easy to summarize their visits to their doctors. When the doctors come in and say, Hey, you got five minutes. What do you got for me? And they're like, uh, you know, they can say, oh, you got so many, this, this needs to go to the IRB. This needs to go to the, um, you know, this needs to be filed. This needs to be clarified. It's quick there. And then the study coordinators on the receiving end, they can just quickly know what to do.
Brad: I love that. It sounds like a CRA tool at first, but I mean, honestly, I'm, you know, I look at things from the site side. I feel like that's great for doing internal auditing or, I mean, hell honestly, I might just hand those to my CRA and say, look, you're going to use these. And this is how we do things here. This is, so you're going to use these and it's going to help us be more efficient at what we do. So, no, I think that's amazing. And again, uh, I think it's, there's a lot to unpack about all that process and more so I think, you know, dedicating a full episode to that is something we should get on the books, uh, for sure. So awesome. Tell us, uh, where we can, uh, work in, people, reach out to you and find you online, Tiffany.
Tiffany: Um, so I'm new to the LinkedIn space, but I'm here and, uh, recently joined and I love, I love the platform. Um, you know, I don't know my head was in the clouds. I don't know, but I'm here. And so you can find me at Tiffany Ashton on LinkedIn, and then also you can follow our Clinessentials page on LinkedIn as well to learn more about the CRA audit notes and some other tools that we have. And yeah, Brad, I think you'll link my contact information. Anyone that's interested in just learning more or have any questions kind of about my pathway, feel free to reach out. I love to help because someone helped me. So I'm always about reaching back and helping someone else. Who's trying to start their journey as well.
Brad: Nope. I love it. And yes, I will definitely put your contact info in our show notes. Uh, I really appreciate you sharing your, your journey with us and, uh, look forward to doing another episode, at least with you. And, uh, I appreciate your time. Thanks, Tiffany.
Tiffany: Perfect. Thanks so much,Brad. I look forward to coming back.