Episode 10: Mone’ Brown, From CRC to CRA
Mone’ Brown is a well rounded clinical research professional who has a passion in many different areas of clinical research. Her passion is Regulatory Affairs in addition to monitoring. She has held roles from Regulatory Affairs Document Specialist, Clinical Research Coordinator as well as Project Manager. She holds a Master's of Science in Regulatory Science. She was unfortunately laid off in March of 2020. Someone hire this woman before it’s too late!
In this episode we discuss the jump from CRC to CRA, the delicate balance between quantity and quality, the value of diversifying your experience, the challenges of job hunting during a pandemic and the importance of integrity.
+ Full Episode Transcript
Intro: Hello, and welcome to episode 10 of the Note to File podcast, a collection of interviews, best practices, and candid commentary for clinical research sites. Today, our guest is Mone Brown. She is a super passionate clinical research professional she's held roles everywhere from regulatory affairs document specialist to clinical research coordinator, as well as project manager. She also holds a master's degree in regulatory science. On this episode, we discuss the jump from CRC to CRA the delicate balance between quantity and quality, the value of diversifying your experience and the challenges of job hunting during a pandemic without further ado, Mone Brown. Alright, Mone, thank you so much for coming on today. Uh, how are you doing on this? Wednesday is today Wednesday. Today's Thursday, isn't it?
Mone: Correct, Today's Thursday and I am doing well. Um, despite everything that's going on, I'm doing pretty good.
Brad: Yeah. It's been a crazy time and it seems like everybody's dealing with it very differently. Uh, all across the country and all across different sites. Some sites have stayed open, some have shut down. Some people have been furloughed. It kind of seems to run the whole spectrum. Doesn't it?
Mone: Of course, you know, I mean, it's a very, it's very trying times, but you know, we'll make it through and everything will come back and be great.
Brad: Absolutely. I'm a, I'm always curious. I always like to start out by kind of asking people how they got into Clinical Research. It's always a just particular interest of mine. I've said it again and I'll probably say it a million more times, but most people don't set out to be Clinical Research Coordinators. So tell us a bit about your story and kind of how you fell into Clinical Research.
Mone: You know, it's pretty interesting. I really fell into clinical research before, before I fell into clinical research, I went to school for medical assisting and I had my, I said that I was going to be working in a clinic just with patients and no clinical research was going to be involved at all. It wasn't the area that I was actually guided into. And, um, when I was doing my externship, I was presented to a company called Clinical Trials and that's how I fell into research. So I ended up doing my externship there and after my externship, they liked me and wanted to hire me on. And so I became the research assistant and they did mainly Osteoporosis studies and Rheumatoid Arthritis studies. And however, um, the office closed down due to the, um, PI passing away tragically. And I kept going on and got my degree in health science and ended up applying for a job for a pharmaceutical company. Didn't realize that I was still going to be in research. And that's where I kinda just stayed and research became my niche. And I went on ahead and ended up getting my masters in Regulatory Science and kept going. So research is something that has become my passion.
Brad: That's awesome. Yeah, absolutely. So you kind of started out very briefly at the site level, but it seems like that was a pretty quick transition. I say,
Mone: right.
Brad: quick obviously you had some, some school in between there, but you had to go from the site to the CRO, uh, role fairly, fairly quickly. And I see a lot of people on a site level who struggle with that, uh, option to be able to, to jump from site to CRO. Do you think that was, uh, in large part due to your continued education?
Mone: I believe it had a lot to do with my continued education. Um, of course I didn't know too much. I mean, I knew some aspects of clinical research, but I did not know as much as I needed to know. When I ended up going to the company on the CRO pharmaceutical level, I learned a whole lot more as far as clinical research and the different aspects of things that go along with research before then, it was just, you know, like it almost was like doing clinical visits even though was considered to be research. But when you go on the CRO pharmaceutical side, you see a whole different level of clinical research from, from beginning to end because you're dealing with the IRB, you're dealing with the, on with the site as well, but you're mainly dealing with the IRB, the FDA, um, how drugs are being made. You're done with validations, all of those aspects that go along with it. So you get a whole different perspective when you're on the pharmaceutical CRO side versus at the site level.
Brad: Yeah. And that's kind of the beauty of it, I think is that there's such a broad spectrum of things you can do that, you know, wherever your interest lies, there's something there for you. Uh, it's just,
Mone: correct.
Brad: There's so many opportunities. So where do you feel, you know, what appealed most to you and across those roles? Is there a particular area that you like the most or that you think that your particular strength is in?
Mone: Of course my strength is in regulatory-regulatory affairs and because, and I was able to start the study and deal with the IRB and dealing with the regulatory documents, also seeing it from a monitoring side and seeing the different aspects as far as regulatory affairs goals and also seeing how to place the guidelines that goes with, um, doing informed consents, um, writing SLPs, um, all the different, um, FDA dealing with the FDA and the different levels that goes along with regulatory affairs and different laws that go along with it and seeing it, you know, everything changes so rapidly and research. You never ever have one of those moments where everything's just going to always be the same things are constantly changing on different levels as far as different laws change with what the research. So there's a con there's constantly things that are changing that you have to stay on top of, especially when you're dealing with, um, different laws that have to do FDA regulations and stuff like that. So you have to stay on top of those things. So regulatory affairs came into play and it helped me with that aspect as far as staying on top of, or staying on top of the different laws that go along with the FDA regulations.
Brad: Sure, sure. And how do you think, uh, or does that sort of trickle down to, to sites? So as far as, uh, you know, being on a regulatory affairs side of CRO, uh, what kind of relationship, uh, do you have with sites and is that, uh, do you think that your experience to being a coordinator in the past had sort of helped helped you better understand how that relationship works?
Mone: You know, it definitely did because you were able to take, take, take your knowledge to the site level. Especially when I was doing, when I was a research coordinator, when I was a coordinator and I was able to take that knowledge and bring it to them because a lot of them didn't have the knowledge that I had as far as regulatory affairs and different laws that go along with the FDA regulations. So I was able to bring that knowledge in and kind of guide them as well. So I had that, um, I guess you could say that upper hand and it helping them as well and understanding different aspects as far as regulatory goals as well. So it kind of helped me in the, in the knowledge that I did have bringing it from the CRO side and bringing it also to the site level so that they had more understanding as well.
Brad: Yeah, I don't think that's, I mean, it's, again, a very underrated aspect of that because there does seem to be a big disconnect sometimes between sponsors, CRO's and sites, we don't see the world of research from the same perspective. It's very different. So, you know, the site level doesn't know what the CRO level knows while the CRO level doesn't know what the site level knows. So I'll get into a lot of, you know, different ways of looking at things and sometimes disagreements just because there's not always a lot of crossover. So I think that's a very, that's a very valuable way, uh, you know, to sort of get in. And it's a great way for you to be able to give some unique perspective, uh, having worked both at a site level and a CRO level,
Mone: Correct. You know, and I'm very grateful that I've had those two aspect levels as far as clinical research goes, because it's always the beginning of trying to help someone else gain knowledge just as well, because you can bring their knowledge into any different situation. And so you can help them to understand and grasp, grasp things a whole lot better. And I have a new perspective and when you're bringing in knowledge, they can bring knowledge to you just as well as you can bring knowledge to them.
Brad: Sure. Well, and I know, you know, being at a site level, if I can tell if I'm having a conversation with somebody from a CRO, I can tell pretty quickly whether or not they've worked at a site level or not, and whether or not they can, you know, we'd have the same level of understanding of how things might work on a higher theoretical level versus a practical level at a site. Because those two things aren't, don't always jive. You know, it can be a trick.
Mone: right.
Brad: So, you know, again for you to have, you know, both sides of that coin is extremely valuable. And I think that's something, you know, even I have experienced where again, I can tell if you've come from a site level, we can talk, we can speak the same language and understand each other as to where sometimes, you know, the CRO level people are, their concerns are just not the same as mine are coming from, from a site.
Mone: Oh, most definitely most definitely because your-, cause you're trying to get people in and trying to get studies done. And then on the CRO level sponsor side, you're like, well, wait a minute, you you're trying to keep data as clean as possible. But sometimes the sites don't the site does not always look at that aspect the way that you're looking at it in a different way. So I know that I was able to bring that into, into light to that it's always quality over quantity. You could have a million subjects, but if the data is not clean, it doesn't make a difference to how many subjects you do have. So
Brad: Yeah, and that can be for sure, that can be a delicate balance at a site level where, you know, we're, you're under pressure to enroll. Uh, and so you've got the competing aspect of, you know, CRO side wants the quality. Well, they want both, I mean they want quantity and quality to be perfectly honest, it's, it can be real easy for quality to get away from you when you're just pumping through subjects as quickly as you possibly can. So that gets, that gets messy. So the, you know, the expectation isn't always match up with, you know, what practically happens, uh, at a site. So, uh, it's important to have, you know, good, good people on a regulatory side to keep things in order and ensure that we're doing what we need to be doing at a site level. So I, I love that. I love that- I love when people have experience from both sides. Cause I think that shows, I think it helps your site be more successful. So that's, that's something that's, you know, should be more sought after and more valued from a CRO side. Because again, I think when you have those combinations of people, the sites are just that much more likely to succeed.
Mone: Correct, correct. Most definitely
Brad: That's awesome. And also it looks like you've, you've had the opportunity to work across a lot of different therapeutic areas, uh, throughout that as well.
Mone: Yes, I definitely have. I've done. Um, I've gotten, as far as, um, cancer studies, infectious disease, dealing with HIV, I'd have the hepatitis, I've also dealt a lot with asthma and nerohrology to name the least. And then I'm also done phase one through four studies, but I've also done. Um, I've done so, so many different areas where I'm not just directed just in one area. I have different therapeutic areas that are underneath my belt, but I'm always open to learn new therapeutic areas because there's so many out there and it's, so it's not just one area that you're concentrating on. So, so I love the aspect of being able to see the different therapeutic areas and to grow in those different areas as well.
Brad: Yeah. I mean, that's what it's all about. I mean, it's, it's never the same, you know, you're always learning something different and learning something new and it really gives you the opportunity to grow when you develop those fundamental skills, then you can take those with you across all kinds of projects and all kinds of therapeutic area. So again, that's what keeps what we do so exciting.
Mone: Yeah, of course.
Brad: Yeah. So what are some challenges that you faced, uh, you know, sort of throughout your careers or are there some things that stick out to you that, uh, you know, might be indicative of, uh, you know, the industry as a whole or just things that have been personally challenging for you?
Mone: You know, um, as far as me as the challenges go, people don't really recognize everything that I've, that I've done as far as research goes. So they try and put me in this box and I'm not in a box because I have different aspects that I've actually gone through and actually experienced and done. And even though I have a Masters in Regulatory Science, doesn't make it any easier for me because it seems like they see that I've graduated. But when the question is also asked, when did you graduate? And because of the fact that I graduated with my Masters in August of 2019, then they think, Oh, was just, is this just her beginning of her experience, but it's not because I started in Regulatory Affairs way prior to me getting my Masters, me getting my Masters was just to open up another door, but it doesn't mean that it doesn't get that it gets easier because it hasn't been an, especially when I was laid off and I'm thinking, Oh, it's gonna be a whole lot easier because I have this Masters in Regulatory Science and you're thinking, Oh, it's going to be a little bit easier and the doors are gonna open, but it hasn't been easy. And then you have to put that into play and you have to put into everything that's going around in the world right now. And it kind of like, puts you at a, almost at a disadvantage per se because of everything that's going on.
Brad: Yeah, no, it's, it's a crazy time for sure. But I mean that additional education should really be just another tool in your tool belt, not, not used as a way to sort of, you know, judge your past experience. Uh, cause again, you've got the, you've got all the background and, and I did the same thing. I started out in research. I had no degree at all. I, I started out as a research assistant at the bottom of the ladder. Uh, I actually dropped out of college, you know, back in the day I got back in to the, uh, back into school, but I started out in research and had to get a degree and then worked my way up through the chain. But uh, you know, those are all it's cumula- it's cumulative, right? It's not, you don't start back over just because you stopped and, or, you know, continued your education so I can understand.
Mone: Right.
Brad: That's a, that's a, that can be challenging, especially with, uh, you know, CR- ugh, I don't know my experience with CRO's is that they're not always the brightest when it comes to picking good talent. Um, and that's not, that's not to speak ill of anyone. Uh, but you know, I've seen a lot of people, they hire who they may have a great education, but they have no idea what they're doing. Uh, as opposed to someone like yourself, who's, you've been there, you've been there and done that, you know?
Mone: Yeah. And I'm no way shape or form any, I'm not in green when it comes to, when it comes to clinical research, I've been doing this for a while. I just went on ahead and tried to expand my, my destiny as far as getting. Expanding my education. It had nothing to do with, okay. I hadn't been in this field, I've been in this field for awhile. So it was just to make me better and improve what I was doing and to learn a whole lot more, you know, when I didn't stay close minded to say, this is why I stopped. So I kept going as far as educating myself to learn more when it comes to clinical research and regulatory affairs and things on that level. So I did stop and I still don't stop. I'll still continue to keep learning.
Brad: Yeah, no, that's that's no. And I applaud you and I think ultimately that's going to pay off for you. I mean, you know, this may be a bit of a dark time, but I think that ultimately that's, that's gonna really pay off for you in the end. Uh, so, you know, keep, keep going, please keep, keep learning,
Mone: of course.
Brad: keep growing, you know, keep, keep adding to your, uh, your CV. And uh, I think you'll, you'll find the right fit, you know, and that's, that's when it'll all click into place for you. I think,
Mone: of course.
Brad: So what are some, uh, some best practices you've picked up along your career? Is there anything you'd share with the greater clinical trial community? Uh, maybe something specifically that, you know, has really stuck out for you?
Mone: I would say integrity to me is such a big deal when it comes to doing clinical studies and completing studies integrity. And as far as getting good quality data, to me, it's very, very, very, very, very important. Um, to me I'm also very, I'm one, that's very, very detail oriented. I do not like queries when I was I'm a Clinical Research Coordinator. I cleared the queries out as quickly as they came and the monitors love the fact that I was so willing to get these done. And when the monitors came in, the queries had already been answered. So what made the monitoring visits go so much smoother, but I also knew what to expect going in on as far as the monitors were coming in and what they were going to possibly be looking for. And so I made sure that, um, the details were there, that the data ended up being good quality to make sure that the studies were going on, if that we're going onward as smooth as possible. So I would say integrity, good quality and making sure that you're detail oriented within your clinical studies.
Brad: Sure. Yep. Nope. That's, that's what it's all about. I mean, that's what makes, you know, not just a good coordinator, but a good employee period, especially in this field where those are highly valued traits to have, uh, you know, I always am the first to admit that I, I'm not someone who's naturally detail oriented. So, uh, I oftentimes envy people like you who, who can have that level of detail. Uh, so again, that'll, that'll take you far, so that's a good, good trait to have and to continue to, to develop for sure. Right. So what are some, uh, some other resources that you've come across or that you use? Uh, is there anything specific even if it's a, you know, whether it's a process or a, you know, a book or just, uh, any kind of general practice that, that you, you like to use to help, uh, you know, further your career that are indispensable to you?
Mone: You know, as far myself i try stay on top of clinical reasearch as much as possible, because it's so important to stay up, stay on top of what is going on in clinical research. Um, because things are always changing. Um, webinars are very important as well because you're going to see different aspects of different areas that you may not know per se, or just to, you know, just to continue to educate yourself and webinars have become very beneficial. Um, I'm also part of the ACRP, which a lot of clinics, those that are in clinical research are part of. And, um, so just, I just, I guess just networking webinars and just staying on top of research and making sure that you're always educating yourselves on what changes that are taking place. And, um, what's new what's out there so that you stay on top of your game.
Brad: Yeah. I know ACRP is definitely a great resource. I think, uh, networking, like you mentioned to me, that's something that I stress to everyone. Uh, it seems like, you know, especially on a site level, there's a lot of, uh, almost, I don't know how to put it. There's people can be introverted, I guess maybe is one way to say it, but there's, there's often guarded. Uh, so sometimes there's not a lot of networking that goes on across sites. Uh, so I always always tell people, you know, if you want to learn something, talk to other people in your field, because everyone's doing things differently, everything's, everybody's getting information from different sources. So the more people you have in the network, the easier it is for you to learn, if it's something you don't know, someone in your network probably does. Uh, so I think that's, again, a super underrated way to sort of keep on top of things that are going on in the industry. So, yeah. Is there anything else you'd like to share with, uh, you know, anyone who might be listening before we start wrapping up?
Mone: Um, I would just say that those who have been laid off, don't give up, keep going. Even if you're on the job search and you feel like you're just getting doors shut in your face and it doesn't seem real, awful, just continue going and never give up, always educate yourself, know that someone is out there that you're, that you will get noticed and just keep going.
Brad: That's it. I love it. Where can people find you online if they want to reach out?
Mone: Um, I'm on LinkedIn, I'm on Facebook. I'm on Instagram. You can email me at any time at secondchancesmb@gmail.com. And if you go on Facebook or Instagram, it's just my name, Mone Brown, and I'm also on LinkedIn.
Brad: Very good. I'll put a link to those in our show notes. Those are available at notetofilepodcast.com a Mone, Thank you so much for coming on. I really appreciate your time. And until next time
Mone: You are so welcome and congrats on your congrats on your podcast.
Brad: Thank you.
Outro: And as always, thank you for listening. Please make sure to check us out at notetofilepodcast.com for show notes, links to resources, as well as contact information for our guests. If you have a question comment, or think you have an interesting perspective to share on the show, please reach out. I'm at Brad@Notetofilepodcast.com. Thanks for listening.