Beyond The Protocol

Transforming Clinical Operations: A People-First Revolution

• Melody Keel • Season 1 • Episode 2

Share episode

In this episode of “Beyond the Protocol”, we sit down with Jeremy Mitchell, MBA, COO at The Research Associate Group, Inc. 

Jeremy to discuss the unique perspective we hold on transforming how organizations support and develop their clinical operations teams.

Key Takeaways:

  • The Human Side of Clinical Trials – Why putting people first transforms operational success
  • Leadership Development Crisis – Addressing the gap in clinical operations leadership support
  • Innovation in Team Development – Introducing The Clinical Operations Leadership Catalyst program

Welcome to Beyond the Protocol—where authentic conversations about clinical research happen.

Hosted by Melody Keel, bringing together diverse professionals from across the industry to share insights and experiences about what it really takes to deliver successful clinical trials.

This isn't about perfect processes—it's about real people sharing real solutions.

Let's go beyond the protocol.

That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials. 

If you found value in today's conversation, please subscribe, share with your network, and leave a review. 

Have experiences or insights to share? Reach out and be part of the conversation.

Join us next week as we continue to discover what lies beyond the protocol.

You can catch it on :

📺 LinkedIn Live

📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol

🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056

🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612

🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7

🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/

This Podcast is Sponsored by The Research Associate Group, Inc.

Melody: Hello. Welcome to episode number two, beyond the Protocol where we're discussing transforming clinical operations, a People First revolution. And I'm so happy that I have Jeremy Mitchell here with us today as my guest. He has graciously agreed to join me on my mission and become a partner with me at my company, the Research Associate Group, as I.

Work to strategize and mobilize this vision I have for transforming the way we do clinical operations in clinical research and focusing on people first and processes second. Welcome, Jeremy. I'm so glad to have you. I'll give you a moment to introduce yourself. 

Jeremy: Thank you, melody. I love how you put it that I graciously joined you.

Anyone that meets you and hears you talking about. The research associate group understands pretty quickly why I would want to be on board and want to be a part of what you're doing. I think far too often we've seen people operations fall through the cracks as we're navigating a clinical operations as a whole.

So the holistic approach and things that you're doing at the research associate group has me excited. I've been in business development majority of my career and. Coming on board with someone who's approaching things in a way that I think can really shape and change the industry has me very excited for the future.

Melody: Yeah, I know we've had a lot of conversations and we have so many ideas and ways that we feel like we can change the world here, and so I'm really excited about just forging ahead and making this happen. For people and for the trials. And most important, I think the downstream impact it has on patients who get the benefit of the research that's done through these clinical trials.

So let's just jump right in. So in my almost 20 years of being part of clinical operations teams mentoring, coaching, providing strategy here in the latter part of my career, I see it over and over again where. We focus on processes, less on people, and then we wonder why we get the outcome that we do.

On the flip side of that, the companies that seem to understand the human investment making sure that our people are happy, they know how to do their jobs, they feel supported, and they're working in a culture that's collaborative and honestly, a safe space to be the best that they can be within the role that they've been given.

Those are the companies that seem to do really well. Even if they may not be as sound and tight on their operational processes, their SOPs may not be as great as some of the other companies, but they're getting the work done in a really good way. And so I think that's what has led me to bring this idea through the research associate group of helping people.

Be better but feel supported and able to optimally do their jobs and within the clinical operations circle. So I'd love to understand how you bring your experience in. I know you are part of an amazing organization as well that also provides support in a different way to the clinical.

Research space. So I would love to just have some insight from your journey that brings you to this point forward. 

Jeremy: Yeah. I'd say in a nutshell, everything that you're talking about is something that we've seen on both sides of the house in the industry, right? It people are hesitant to participate in trials because they don't wanna feel like a number.

They don't just wanna feel like they're on an assembly line. That goes the same way for people who are performing the trials, right? All of our people that are putting in their blood, sweat and tears wanna feel like they're actually valued. And I think that's one of the things that's so exciting about taking this approach is that not only are we upskilling people where they can understand how to do their job more effectively, we're also taking an interest in.

We know that you probably have other aspirations. How can we put you in the best place to succeed? We're not just going to replace you, easily. We want you to be here and we've invested in you. And it benefits us as a whole to make sure that you're in the best position to win, right?

So I, I think that as we continue to work with people on this side of the house, in the industry. We will see that their approach will resonate more on, on the outside as we're dealing with the public. Who doesn't really understand? I believe, as a layman, I've only been in clinical research now about five years, so I still tell people I, I see it from both sides, right?

I'm an outsider still, so I know what the, that type of people are saying and what they think. We didn't understand what clinical trials were and, and what this industry was all about. The only time we hear about it is in, unfortunately, a lot of times in negative stances.

So I think that if we can figure out a way to have people feel more confident in their role, so as they're dealing with, non-industry related people, that will play off very well. Yeah just awesomely excited about this. I hope you can see the passion that's coming through on that.

Every time I talk 

Melody: and I do, and I know we meet. Almost daily, whether it's emails, meetings, and everything. And I think our passion is really what connects us, like the excitement of the opportunity to make a change and make a difference. Not only for companies, yes, but for the people. There's so many people that we talk to and we connect with and we engage with through our communities and professional and personal lives.

And they need to work. They wanna feel fulfilled in their, in the work that they do, but oftentimes they're so miserable. And when you dig in and you have conversations with people, they're not miserable because they have to go to work. A lot of times they're miserable because they don't have the support they need.

They're not working in the culture that inspires them and makes them feel valued. They don't have the professional development and tools to give them what they need to get the job done properly. Working in a compliant environment, not getting the job done properly and your name is on it, can net you some trouble down the road, right?

And so working in an environment or a silo of fear not being able to understand exactly what you should be doing and just getting thrown in, which is what a lot of us, what happens to us. We get thrown in, we're in one role, and then all of a sudden we're thrown into the deep end of a swimming pool because there's a resourcing deficiency or there's something that's happened that we weren't truly prepared for, but we got thrown in, and then we need to figure out how to swim and succeed.

And I think that's what I'm really on a mission to change, because that approach isn't good for the person that's in the role, but it's also terrible for our trials. So when we're looking downstream and we're wondering why our database locks are horrific because the data's terrible and we're having to go back and figure out how to scramble and clean things up, our monitoring is behind or not at the best level of quality we would expect it to be.

Like all these things that can happen, right? And the challenges that our teams face. It's just, it is the nature of the beast for us in this industry. But we can still do better. We can still bring a human side to it and stop focusing just solely on processes, right? And so I think that's where we are and we are decide, we have decided to focus and take this approach directly to the organizations.

I think that's where we can make the biggest impact when we can really impress upon leadership at these organizations. Your people are sinking and they need help. And the help doesn't have to be a million gazillion dollar super strategic plan that no one can wrap their minds around and sustainably execute.

I think we make it too hard when we think of getting people in or programs in to help our team succeed. It just doesn't need to be that difficult. And I like our simple approach. To bring practical support to teams. Practical strategy, practical day to day, this is how you should do your job. What are you missing?

What's needed? How can we help you be successful? I think it's so simple that it's just overlooked, and I'm glad that you and I are on this mission to bring this forward. I'd love to hear what your approach is or how you feel. We can take this to organizations because I think it's new and a lot of times in this industry not a lot of times all the time, we like to do things the same way that we've known.

We don't wanna try anything new. We don't wanna step outside the box. We've always done it this way. We're not interested. Thank you. Have a nice day. So what is your approach in how we will meet and greet organizations that could really benefit from what we'd like to do in the industry? 

Jeremy: So I think that one of the big things that you hit on there is a problem with a lot of industries that have had success, where they get comfortable and instead of saying it's a new day and it's a new time we get complacent, and.

Too often complacency leads us into a point where people are burned out and people no longer want to continue in these roles. So I think it's important that we present this as, yes, we are a clinical operations strategy company. We can help you from A to Z on that level with tons of experience there.

But we also understand what it is to navigate the journey to. Higher levels than in companies. So understanding that too many of these people have been placed in roles where, honestly, once they get the role, the training just stops there. So we've set them up for failure and there's nowhere for them to go from that point, because now, to your point, their name is connected to, failing trials or, data that people look at and go, no, there's no way we can use this. So I, I think understanding that. Training and development doesn't end when someone sits in the seat that it needs to continue. All throughout their career. And allowing people to understand that we have a program that will meet these people where they are, if it's a virtual community, we have that if it's an in-person community, we have that the opportunity to, help people that are already.

Short staffed. Let's face it, the industry is in labor crunch right now. We have layoffs in a lot of companies and then we're asking these people to do the role sometimes of two and three people, and that's just, not something that's a recipe for success, especially when they haven't even been given the skillset necessarily to do their original job.

So these.

We want to place people in a position to succeed. And our program has that, the capability, because you're talking to people who have navigated this journey, right? If we're putting people in front of your team, it's people that have done this, that have been successful at the highest levels, and have handled multimillion dollar budgets, have, ascended through companies to the very highest levels.

So I think what you want is that you wanna align yourself with companies that give you the biggest bang for your buck, right? So what we're saying is that we have these people with this wealth of experience. Wealth of knowledge. We've created this program, something that normally, you would have to have four and five people doing this that we're doing.

We're training your people individually to basically level up. So we're cutting down some of your costs because you're not having to put six and seven people in this seat. We're gonna train up the people that you already have there to be more effective and more efficient in what it is that they're doing.

And let's be honest, at the end of the day, we're a bottom line business, right? Yes. Yes, absolutely. In our profitability. And the way that we do that is holding onto the big talent and helping them improve their skillset so that they're better at their job and they don't feel overwhelmed.

You alluded to it earlier, you know what my other side of the house career is? As the head of sales and business development at Black Women Clinical Research, I constantly hear from these team members who talk about, yes, I got this role, and that's great. I don't have any support. I feel like I'm out here on an island.

How is that, a recipe for success when I feel like I'm alone and nobody's there to help me and when I do reach out to a manager, they're so overwhelmed, they can't offer me that one-on-one attention that I need. That's where the Ssociate group comes in. We stand in that gap for these companies that are already strapped for resources and say, we can help you do better what you've already done in a way that you probably haven't thought of doing it before.

We have a whole plan in place to just make your team overall happier, more efficient, and just more viable a whole. 

Melody: I agree. I agree. I fully agree and I think, in the current climate as I speak with people, you may be miserable, you may feel unsupported. You may not be happy in the role or the company that you're in, but you aren't going to resign in this current situation that we have going on around this.

And so what does that mean for an organization where you have people that feel that way? They're not going to resign. And I know I did an article a month or so ago about quiet quitting. It is real. It is really real. And organizations that don't acknowledge this and find a way to address it and turn that kind of large sinking ship around will find themselves with teams low turnover, but no pro productivity.

If you have it, it's not done well, and your trials are impacted. In a very negative way. And this can all be mitigated, not it can be mitigated with some thoughtful planning and strategic partners who can come in and support your teams in a way that you may not be able to internally.

It's just simple as that. Again, simplicity, stop making things so hard, which is something we really like to do in our endage.

Jeremy: I was telling someone that the other day, melody, that, think of the research associate group. We're a specialized surgeon, right? We come in, we can recognize the need and actually impact the areas that are suffering instead of just trying to do a cookie cutter approach. We're very surgical at how we can come in.

So I think that's one of the things that, that just makes us better. 

Melody: I like that analogy and I think I, a lot of my friends and colleagues they call me the fixer. I like to come in, I like to figure out what's wrong. A lot of times the problem is something no one else wants to touch. So it's just growing and growing and I like to come in and figure out how to fix it and make it something that doesn't continue to just grow and grow and become a cancer in the organization.

There's always a fix. There's always a solution. It may not be easy to get to the end zone, but you can do it and you can get the team behind you to be part of the solution. And then it's rinse, wash, wash, rinse, and repeat. So next time something comes up like this, not only did you have one individual that could fix the problem, you've now infiltrated the organization and the team, and they are able to do that.

So we're not only feeding, we're teaching them to fish. And I think that's that's where the magic happens for me. So I know you and I are so excited and we haven't shared with a lot of people yet, but I think this is a great opportunity just to share a little bit about this program we've referenced.

In the 20 years I've been working, I've always been part of teams. As a consultant and gone in and done what I am talking about doing here with the research associate group, but I realized that there's only so many hours. There's only so many clients you can have as an individual. And I wanted to scale.

I wanted to be able to help more people at a larger level. And we've developed this program that you've referenced already. It's called. The ClinOps Coaching Catalyst, and essentially it's a container where we can bring ClinOps team members in to get this professional development, this training, support, mentoring, and just practical day-to-day support for doing your job and figuring out how to do it well.

I think some examples I talk a lot about, budgets and you have $20 million studies a lead that's been assigned to a study, and that individual is responsible for overseeing the budget and making sure the framework is maintained. But if you don't know how to do projections and accruals, and you may be at a company that doesn't have a very robust finance department or very technical.

Piece that supports that financial aspect of the budget, then it can become very manual. And what do you do? How do you manage that? A lot of people don't know. They're not sure about that. And so you mean to tell me you're essentially have someone with a blank check approving invoices every month or quarterly and they have no idea where they stand in a reconciliation perspective of a budget.

How do you do that? This container. Is a resource to be able to get someone that information and that knowledge base so that they can then go back and put it into place in their day-to-day life. And so I'm really excited about this program and the technology that we're building for it to live within.

I think it's innovative. I think it's definitely a way for us to achieve what we've set out to do. And not have to be limited in the number of companies that can send their team members to get help. I think you and I were talking a couple weeks ago and I was saying, we go to conferences.

I've been to conferences. They're wonderful. I enjoy going networking, meeting people, but I often lead that conference feeling like I didn't have anything tangible to take back with me for the day to day. So I still don't know how to do some of the things. I came into this conference not knowing how to do.

I met some wonderful people. I gained some amazing insight about the industry and where it's headed, but for me as an individual and others what do I do when I leave this conference and go back to my desk and I'm back in the day-to-day grind of delivering the outcomes of this trial. And so I think this is a gap.

We're filling a gap. That is not met right now, and I'm really excited about that and I know you are too. 

Jeremy: Yeah, absolutely. One of one of my favorite books is by an FBI in what is his role? He is a negotiator. Chris Voss never split the difference. And this man is what I tell you, he's probably the Michael Jordan of negotiation, 

Melody: right?

Yeah. 

Jeremy: And as I think about what it is that we're building here, I can equate it to him. He's going all across the country, he's doing these classes and everything, and how excited people are to sit in a room with someone who has that ability to really get you to do whatever he wants you to do.

He knows how to meet you where you are. And it, it's just very exciting to me that I feel like your knowledge is in this space on that very same level and where you've been able to impact. Companies on a one off basis. What we're saying now is that we have something in place where we want the impact to be massive, and the only way to do that was to create a program.

Like this where no longer are we, just putting you into one spot and saying, okay, impact this company. We're saying this knowledge and this framework that's been put into place. We want it to permeate the whole industry. And it's something that as companies, in invest in their people by signing up with the research associate group, I.

Very soon we'll be talking about the impact that you've had in the same way as I do when I'm talking about a Chris Vos, you know anybody who's in sales, you mentioned this book, their face is gonna light up because they know who he is, right? It's the same way here when someone has a wealth of knowledge and you figured out a way to get that knowledge to the masses.

I think every company should be excited about that. The, we're giving them knowledge that has taken, like you said, over 20 years to create and to perfect. And we're putting it into a digestible way that, again, people can leave with actionable. Capabilities going forward. It's not something where they're gonna sit in these meetings that we've all set in before, not just at conferences, trainings, even where we set in those trainings and we're our heads doing this and we're falling asleep, that's not what this is.

This is something where you want to be on the edge of your seat because it's engaging, it's relatable. The day to day things that you go through, that is what this program is built on. Yeah. Very to see the impact and believe that, like I said very soon people will be on meetings like this quoting, melody kill and saying how phenomenal she was and what she built at the research associate group.

Melody: I appreciate that. And I'm the behind the scenes girl. Oh. I'm learning to, I'm learning to, let that go because I can't continue to be the behind the scenes lady and make the impact that I'm really hoping to make in our industry. And that's what it's about. It's definitely, it's not about me.

Fortunately, there are so many more incredible professionals that have the experience. They have lived the battlefield right, of clinical research and they are able to share that and let other people tap into that experience so that they can become. The next first class group of leaders in our industry.

And so that's what really makes me do the happy dance about this is because a lot of programs just focus on one level, new people to the industry or middle of the road career folks or executive leadership. But I really am working to find a way to. Support everyone and meet you where you are in this program to help you go to the next level.

And then the other side of that coin is as you're going to the next level, the organizations benefit because their clinical trials get the result of you improving your skills and understanding how to do research in a better way. 

Jeremy: Yeah. And I think we, we have to admit that continuing to do things the same way isn't gonna work, right?

We are doing something that saves and changes people's life. So shouldn't we always want to be on the cutting edge and stay innovative as possible? I. While we're, navigating everything that's changing the new climate and everything, we wanna make sure that we are adapting, seeing, sitting back, being reactive isn't a way to go when we're talking about people's lives here.

Be as proactive as possible and that is exactly what the research associate group has done. 

Melody: I agree. And I think, I'm so glad you said that because our industry is. It's, we're getting ready to see a seismic shift. I really do believe that. And it's just because of where we are in the time that we're in.

And so we have ai, we have all this technology coming. We, we have some unknowns right now about our industry and what will happen and will our research and development budgets still be the way they are. Are we gonna have to do some tightening of the belts and figure out how to continue to do research at the same level, but.

Maybe not with the same level of resources that we've been able to use. And so I think now is the time to begin to understand what the future looks like and how you retool and prepare yourself. And that's from this perspective of the organizations, but also from the perspective of the people. That work at these companies and employability is changing.

And will we always look, will we always have will it always be that we get hired, we interview, we get hired, we're employees of the company. I. And that's how we have our livelihoods maintained, right? I think the workforce is changing, and so we also have to look at that and see how do we fit in and adjust as people who run trials for organizations.

And so there's so many factors to this that need to be addressed and can be addressed within this program to help people and organizations. And at the end of the day, that's what you and I are really on a mission for, to focus on the people and to build the culture and then let the processes get worked out and strategize those so that we have a 360 degree working wheel that gets us to where we need to go.

Jeremy: Absolutely. Absolutely, and I love that, it fallen through the way too many times where. Try to elevate our people and make sure that they're happy with what it is that they're doing. I don't know about yourself, but I can remember the job that I was happiest at was I was 16 years old working at a movie theater.

Not making a whole lot of money, but the culture was good. We enjoyed working with each other, and we had a great time. And that job will always stick with me, because it felt like I was a part of something and I felt valued. Now looking back. Maybe it wasn't ever, as glorious as I thought it was then, but you couldn't tell 16-year-old Jeremy that, this isn't the way that all companies are gonna run or the way every job is gonna be where I'm happy to come to work.

I'm excited looking to, what's next. I think that by putting something in place and having organizations partner with us. They're showing that investment to their people. Yes, we pay you a very good salary. We know these are very well paid roles in clinical research, but it's more to it than just the money, right?

I can find money in a lot of different places, but can I find happiness and contentment with my day-to-day where I don't dread Mondays? You shouldn't have a case of the Mondays. Every single week, right? For myself, I look forward to getting up on Monday morning because I know, you and I are gonna have our first call of the week and we're gonna plan out on what we're doing next for this company.

So that's the way that I think partnering with us benefits these companies, right? We want employees that feel valued, that feel respected, and feel like you have a vested interest in their success. And you do that by. Using the resources that we have and aligning yourself with, the program that we have in place.

Melody: I agree. I agree. I think that the folks that have joined us today will be able to, I hope they feel how passionate we are and is just oozing through to them and it fires them up. It gets them excited about finally something available that is tangible and I can use. It has a human factor that a lot of others don't.

So a human factor and a continuity situation where you're not just going to a two day seminar and spending time in a room and getting some information that you have to go back and figure it out, but something that is just available to you every day in the way that you need it. And I think that's what makes this really cool.

More to come from the research associate group and the two of us. We're really looking forward to continuing to speak with people and meet with people. And I think if this resonates with you, then you should reach out and find us on LinkedIn. We're always happy to have connection calls as one of the highlights of my days when I see I have connection calls booked on my calendar.

And I appreciate you, Jeremy, for joining us. On episode number two, this is a new show, right? But I think as we progress and we continue to have guests on, I think it's gonna also be a value add for people to just get some nuggets, to get some different insights and to have the opportunity to engage with us and provide their feedback and insights which we would love to hear and even have them on as a guest.

So I'm really excited about this new show and what it can do to help get. Our mission out there to the world. 

Jeremy: Absolutely. Good information is vital, in whatever industry that you're in, and I believe that this platform will be a value add to anyone who takes the time to invest in themself and say, Hey, I got 30, 45 minutes.

On the treadmill. Let me listen and see what the research associate group talking about today and understand something that can be actionable for me to take into my day to day. So really excited about what we're doing and what's next. And I believe the sky's the limit and can't wait for everyone to join us on this journey.

Reach out as Melody said jmitchell@theresearchassociates.com. Send me an email.

Melody: All right. Thanks Jeremy. I appreciate you and everyone will be hearing from us, I'm sure again.

People on this episode

Head Shot

Melody Keel

Host