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Beyond The Protocol
Successful clinical trials aren't just about processes and protocols - they're about the empowered teams and supportive cultures behind them.
Beyond the Protocol is a live show and podcast where Melody Keel brings together diverse professionals across the clinical research landscape: from operations teams to industry experts, all sharing insights on what it takes to deliver successful clinical trials
We dive deep into the human side of clinical trials, exploring everything from team dynamics to operational challenges, leadership development to cultural transformation.
Each episode features authentic conversations with industry professionals who understand that true excellence in clinical research starts with supporting the people who make it happen.
Ready to discover how empowered teams drive exceptional trial outcomes?
Join us as we go Beyond the Protocol, where we believe that investing in people is the key to clinical trial success.
Beyond The Protocol
When Leadership Looks Like Us
Building Representation Into the Trial
Clinical research can’t scale without inclusive leadership.
In this episode, Melody sits down With Danielle S. Mitchell founder of Black Women in Clinical Research (BWICR).
we go into the operational impact of building leadership that reflects the communities trials serve.
We explore how representation isn’t just a DEI initiative, it’s a business-critical lever for retention, execution, and trust across trial ecosystems.
- Why lack of representation drives burnout, turnover, and underperformance
- How BWICR and Noir Research Collective are shifting the clinical leadership pipeline
- The link between visibility, mentorship, and promotability in trial teams
- Why inclusive infrastructure is essential for long-term retention and quality
- What clinical ops leaders must unlearn to create equitable, high-performing teams
This episode is for everyone who believes that building diverse, inclusive leadership isn’t just the right thing, it’s what makes clinical research work better for all of us.
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.
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🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/
This Podcast is Sponsored by The Research Associate Group, Inc.
Melody Keel: All right. Welcome back to Beyond the Protocol, where I'm super excited to have my guest today, Danielle Mitchell, who I think many of us know as the founder of Black Women in Clinical Research and is definitely pioneering and leading the way for inclusion in trials. And so I'm super excited to have you here today for us to have this conversation.
Um, when, how the importance of having diverse leadership, right. In our operations and clinical trials and at the companies that are running research. So, welcome. I'm so happy to have you here today.
Danielle S. Mitchell: Thank you so much, melody, for having me.
Melody Keel: Yeah. So let's just dig right in. Um, I'd love for you to kind of share with us your journey, how you got into research.
Um, many of us fall in, right? Um, so let's hear your story and, and see, um, how you landed to where you are today.
Danielle S. Mitchell: Yes. So I like to say, and Quincy Ong as well, Dr. Quincy Ong likes to say this as well, that clinical research chose me. So I wanted to become a doctor, and I remember very early, um, when I went to Clark Atlanta University, I had a bachelor's degree in biology.
I just knew that I was gonna be A-O-B-G-Y-N because I helped deliver, uh, my baby sister. But when I got to college, I decided to pivot and there weren't a lot of career options for someone who has a bachelor's degree in biology. And I remember at the time some of my career choices, um, were either I could work at a lab or I could become a teacher, and I decided to work in a lab, but I knew that I wanted to make a greater impact.
And I ran into a college classmate about 10, 15 years after, um, my college. Um, after I graduated college and she told me that she was a CRA, she said she gets to work from home, she gets to travel, and she was making over six figures and I was immediately interested. And so that sparked my interest in the clinical research industry.
But I realized very early on that there were challenges with getting into the clinical research industry. It was as if my transferable skills weren't transferable. Every clinical research role that I applied for, I was rejected. So I began to think that I had failed in life, um, because I didn't go to medical school and I was applying for all of these clinical research roles and no one would hire me.
But I was at the point where I had tried everything under the biology umbrella. I did, uh, I tried to do forensic science until I found out that they said that, um. If you are on the scene of a crime, us, a killer can come back and, um, hurt you. So I decided, okay, maybe that's not for me, but I, yeah, I was like, that's not, that's not, I don't, I don't, I don't want that in my life.
Um, but I also did a microbiology, I did clinical genetics, so I was at the point where. Clinical research had to work for me. Yeah. Um, and I was going to give it my all and do everything in my power to get into clinical research. So I went on clinical trials.gov and I began to cold call the clinical research sites, asking them, can I shadow?
Can I do an internship? And it just so happened that one of the clinical trial sites that was in Smyrna, Georgia. They allowed me to be an intern. So during that time I did Uber Eats, DoorDash, Amazon Flex, you name it. I did it just to gain that clinical research experience and that gave me the foundation that I needed in order to start my career in the clinical research industry.
So I always tell people, you know, not to give up. You know, the industry. Yes, you can receive rejections, but don't take that No. As a final answer. Agree.
Melody Keel: Agree. I love how our story has, um, so many similarities. I plan to go to medical school. Um, a lot of people that know me personally know, um, I focused on partying more than academics my first semester.
And so medical school. And my GPA probably weren't in the cards to align at that point. Um, and I went on to grad school biology degrees, all the things, and realized I don't like rats and so I don't like mice. And I worked in a forensic science lab too. Um, but I didn't do anything with the science. They had me logging files into an Excel spreadsheet like days after, days after days.
And I was like, clearly I don't have a master's degree. Just to do this for the rest of my life. Um, and so I, I fell into clinical research too, and I think it's still very much the same case. Like I speak to people today and you have a whole entire organization and community committed to helping people get in and flourish, right?
Thrive and the industry. And it's still such a challenge, right? For people to get in and people to stay in and really do well. So I think we have come a long way, but we still have a lot of work to do,
Danielle S. Mitchell: right? Absolutely we do. Yeah. And you know, there's such a lack of diversity in the clinical research workforce and you know, a lot of times the conversation that I have with a lot of people, they say, oh, there's a lack of diversity in the patient population.
And I always look at that. Where the numbers are similar, the numbers, the, the lack of diversity in the clinical research workforce is similar to the lack of diversity in the patient population. So to me, I feel like it's connected. If we as a community, the clinical research professionals can tell our community that.
I'm a clinical research professional. This is why clinical trials is important. I feel like that would create a major shift if we, as a clinical research professional start going out into our community and tell our community about. The importance of clinical trials. And so I'm a walking clinical research advertisement.
I'm always wearing my shirt when I'm getting, um, uh, just recently when I, when I'm getting, um, on the airplane, I have my, um, my gear on my, my B-W-I-C-R gear. This, uh, past weekend, I actually met two clinical research professionals on the airplane and at the airport standing in the security line. She just happened this.
Like we were just talking. And that's why I tell people you never know, you know the conversations that you have with people and networking. So she just told me that she was going on a site visit and I said, wait, are you a CRA? And so we just sparked up a conversation. Um, so I just think it's important to, you know, to always network and you never know who's standing next to you.
And it's just an opportunity to talk and to share, um, with people. I agree
Melody Keel: and I think, I think representation matters for that reason because when people see others that they can relate to. That's when they're interested. That's when we'll get patients who, um, are not necessarily represented fully in clinical trials.
Now, that's when they'll start to come in and ask their doctors about trials or seek out opportunities to participate because they see people that are in it, on the professional side, like you said, their doctors are participating as investigators. It's just an entire ecosystem that we have to nurture in order to make representation really a realistic.
Um, consideration
Danielle S. Mitchell: in our industry. Absolutely. My cousin reached out to me and told me that she was considering, um, being a clinical trial participant, and she told me that the only reason that she was considering, um, being a or is because of me.
Melody Keel: Mm-hmm.
Danielle S. Mitchell: And so, and, and because of, you know, what I post on Facebook, what I post, and you know, just, just being that, like you said, being that representation for your family, for your community, it's important because it makes clinical research and clinical trials not as scary.
Like if you know someone. That's involved in it is not where clinical research is so far removed from you that you have no idea what it is, but you have a person that is close to you that you can ask questions. So she was able to ask me questions about the clinical trial and I was like, yes, I'm, I'm very familiar with this clinical trial that she was asking about.
So I just think that it's important for us to show up for our family, for our community to be that voice that our community needs. And I think that
Melody Keel: that's an answer right there for the leadership. Um, the folks that are in the day-to-day of trials, whether you're on the site side or you're on the, uh, sponsor side, or you're maybe a vendor that supports recruitment.
That is the answer. It's not identifying patients. It's making sure the patients that we identify are educated about clinical trials. They trust the people that will bring the idea or the consideration of the trial to them. And they have an advocate that they can go to and say, would you do this? Can you help me understand what this means for me?
And so that's how we improve and increase diversity in our trials. And so I love that. Your cousin calling is a spot on example of how it works, right? What it, what it looks like in real time, um, to really reach those that we're trying to pull into this industry ecosystem of clinical trials. And so I wanna kind of move into, um, mentorship.
Networks and inclusivity. And I know there's a lot happening, you know, right now with DDEI and what is that? What does it mean exactly? And it's not just, it's black and white sometimes as we wanna make it. Um, and I love that your organization, black women in clinical research. Is inclusive for everyone.
It's not just black women that you invite into this organization. It's everyone in support of improving diversity in clinical trials. So I would love for you to kind of share, um, your vision and your view on mentorship and networking and why it's so important in our industry.
Danielle S. Mitchell: Absolutely. So with the Black Women in Clinical Research Conference, everyone is invited to attend.
And also with our Zoom meetings that we have, um, our monthly career events, we want everyone to be involved in this process because we know that it's gonna take more. Than just us. Um, you know, I would say leading the path, like we need everyone to be included, um, with the efforts that we're doing. Like we can accomplish so much more if we come together instead of everyone doing their own separate, uh, I would say initiatives.
So I'm really big on collaboration and partnering and seeing how we can help one another. Um. What we have done with mentorship. And so we allow the B-W-I-C-R members to be a part of a mentorship program. 'cause it's so important to have a cheerleader. It's so important to have someone in your corner that's rooting for you and a person that you trust.
And so we allow our members to, we have a mentorship matching. Software that will match our members with other, uh, seasoned clinical research professionals. And so that is one way that we are helping our members and a lot of our members have received, you know, new job opportunities from our mentorship program.
And they've also been able to receive promotions as well, just by having someone that is pouring into them and telling them things of, on how they can improve their chances when it comes to these roles in the clinical research industry. And we also talk about the power of networking. And like I mentioned before, you know, networking at the airport, networking, you know.
On the airplane, I, I do it all the time. Networking is a part of me and I tell people that if you really wanna take your career to the next level, being able to network, being able to have your elevator pitch ready to go, being able to tell someone exactly who you are and what you are trying to accomplish is so important.
You're able to connect with so many people. You never know if the person next to you can offer you a job opportunity or you never know if they can connect you with someone that they know. You never know who knows who. So it's always important to bring your A game when it comes to networking and to go on LinkedIn and make sure that your LinkedIn profile is up to date because people are searching.
For you, people are searching on LinkedIn to find someone, whether it's to, to fill a role or find someone to network with, or to introduce them to someone else, so it's so important. I, I always tell people LinkedIn is a gold mine. Networking is so important. Your brand, presenting yourself, you know, and really letting people know who you are and what you stand for is so important because your reputa, your reputation is, is important in the industry, and you wanna be able to have these connections to help you grow professionally.
Melody Keel: Agree.
Danielle S. Mitchell: I, I
Melody Keel: agree and I'm so, I'm such a proponent of LinkedIn and branding yourself. Whether you're happy in the role that you're in, or you're looking, or you're hoping to promote or just get into the industry, you have to have a presence on LinkedIn and not just a presence, but a brand. Um, people should be able to see your thoughts, your experiences, um, and know exactly what you are.
What you're committed to, your mission, whether it's looking for a new position or offering thought leadership, whatever it is, I should know just by going to your LinkedIn profile. And I think many of us are missing opportunities because we're not getting in the game with LinkedIn and it's just not that hard to do.
It really isn't. So I'm, I'm a staunch advocate for people ensuring they are. Present on LinkedIn and, um, not just silently watching from behind the scenes. 'cause they're gonna miss opportunities and networking opportunities. Um, so I, I would definitely move into your conference. I think it's amazing what you doing with the Black Women in Clinical Research Conference.
Um, I'm excited to be part of it this year and contribute, and so I would love for you to kind of go into that. What was your vision when you decided you were gonna do a conference? 'cause that's a major feat within itself. And then to have one and then do it again and now you're doing it again. That's a, that's a major accomplishment in my mind.
'cause it's not easy to do the conference in, in any industry, but definitely in this industry. And I see it growing. Really being a valuable asset to the people that, um, are part of it. And, and I would love to just understand how it even became a vision, a thought
Danielle S. Mitchell: for you to do this. So back when I created black women in clinical research, that was always a goal of mine to have a conference that doesn't feel like a conference.
And a lot of times when you go to a lot of clinical research conferences, you have people trying to sell you software that you, you're not the decision maker. So a lot of times you're like, okay. Yes. Like this is great. This is great. But yeah, I be like, I can't do anything with this information that you're giving me.
So I wanted to switch, switch it up when it comes to the Black Women in Clinical research conference, because most of my members want to learn more about the company. The roles. So I wanted to have it to where at our conference you can talk to someone about job opportunities, you can find out about work-life balance and the company culture.
So I wanted to switch it up to where someone isn't trying to sell you a software that you can't use, but an opportunity to really get to know the company and to get to know the people that are there. And just from the past conferences that we've had, you know, people have been. Hired on the spot. Um, there have been people who, um, worked for the company and just because they went to the table, um, of the company that they work at, they were promoted.
So you just never know. And I wanted, I wanted to make sure that. The black women in clinical research was different than other conferences. Yes. You know, doing, doing different things where people had never heard of, you know, having a career fair at a conference, um, having, you know, a meet and greet. Having music, just having good vibes, good energy, where you're not like, oh my goodness, I'm in a, another boring, you know,
Melody Keel: concrete fit in.
Where do I fit in? Because I think a lot of times people don't realize that. For research professionals, um, that are brown and black, oftentimes you're my, you're the only one in the room, and so to be in a conference where you're not the only one in the room, that's huge. That that means something.
Danielle S. Mitchell: Yeah, the music, like, it's just, I tell, I tell people, and my husband has said this too, it's like a family reunion, right?
Um, it's like the conference that you never knew that you needed and going to the conference and just seeing people who look like you, talking about topics that are relevant to you and your career growth, like it is an amazing. Conference to be a part of. And I, I'm so glad that we are able, like you said, it's not easy planning a conference and this is our third annual conference, so coming up with different topics and making sure that, you know, people are like, these topics are relevant to our members and I just wanna keep making sure that I'm making these.
Topics that people wanna hear about. So this year, uh, I guess a, a sneak preview of what we're doing, but I wanna have a topic where we're talking about skincare and haircare and, you know, different things that a lot of, um, you know, a lot of our members have mentioned. Just topics that we haven't touched on or a topic that hasn't been talked about at a clinical research conference.
You know, those are some of the things that I wanna touch on, um, at the Black Women in Clinical Research Conference. You know, maybe we might even have massages at the, um, conference because a lot of us, I'll say a lot of us, you know, don't really have that time to unwind and a lot of special. Like a lot of us are, you know, working, you know, at a high level, but we don't have that downtime.
So I wanna make sure that we are pampered and just, you know, having the best experience that we can have in, in this industry with people who look like us and, and people who are supportive of our efforts.
Melody Keel: I love that. I think that's great. Um, I know that there's opportunities for sponsors to join you and collaborate with you on the conference from that side.
And I also know that, um, I think it's expected to sell out, right? So if you're interested in going, you probably should book and, and get your spot. Um. So I, I, I just wanted to put that shameless plug in. But the, the other thing I kind of wanna wrap us up on is what is your vision for black women in clinical research going forward?
What's the future and how do you plan to continue to impact our industry in such a positive way?
Danielle S. Mitchell: So with, with black women in clinical research, I want to continue to be, I would say that beacon of light, um, for the industry and to be that organization that is moving the needle and doing everything. In our power to move the industry forward.
So collaborating with a lot of, you know, CROs and pharmaceutical companies, I think that that is really important. And also building our clinical research workforce, um, being able to have the resources and the tools in order to make our members, um, successful. And also reaching back into the community.
Telling our community about clinical research, so whether that is middle school, high school colleges exposing students early on to careers and clinical research, so they don't have to wait till they're in their thirties like myself to find out. Just fall in, we can stop to just fall in situation. And making, making clinical research a part of STEM programs.
And also, you know, I was thinking about this, um, earlier, is, you know, when they have take your child to workday, I feel like the indu, the clinical research industry, we need to do a better job and with letting. Our families and the, and the, and people's kids know about these opportunities. So we need to do a big push when it comes to take your child to workday in the clinical research industry, because this is a hidden industry, right?
And so letting you know, even if you don't have kids, take your, take your cousin. Take your nephew. You know, like, yes, take, take someone, um, in your family and let them know about what you do. So I just think that it is so important. I do too. I do
Melody Keel: too. Well, I appreciate you joining us. I think, um. Um, I, I think, you know, that how I feel about you and black women in clinical research.
I, I think you're doing amazing work and I really, um, am happy to encourage you and, and to be a part of it in any way that I can. And I'm so glad you were able to take time out and join us today for, uh, to talk to the community about the wonderful work you're doing and how they can support it. So I appreciate you.
Danielle S. Mitchell: Thank you so much, melody. Thank you. I really appreciate it.