Beyond The Protocol

AI Is Here …Now What? Evolving Teams & Training in Clinical Research

• Melody Keel • Season 2 • Episode 1

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AI in clinical research isn’t just changing how trials are run, it’s reshaping the roles, skills, and support teams need to succeed. 

In this pilot episode of Season 2, Melody Keel explores how clinical operations leaders can keep pace with AI-driven innovation while investing in the people who make trials happen


 • How AI is transforming trial design, data analysis, and patient engagement
 • Why traditional training approaches are failing in a tech-first environment
 • What adaptive, ongoing professional development looks like in 2025
 • How to lead teams through uncertainty, fear, and skill gaps
 • Why culture, clarity, and curiosity matter more than ever


 This episode offers real-world insight for clinical leaders balancing technological disruption with the human need for growth, stability, and purpose. 

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

Welcome back. I'm so excited to have everyone join me for season two episode one. I'm incredibly grateful for everyone that's been following me through this journey of starting this podcast and having this show. And thankful to the guests that have agreed to spend their time with me to today. Last season was amazing.

I think we had some really great conversations and I'm so excited to continue that forward. I think you're gonna enjoy the guest lineup that we have planned for season two and just to continue the discussions and to experience the passion that so many of us have for the industry that we've chosen to have our professions.

But it feels like so much more than just a career or profession for me, and definitely the guests that have joined me. So I think. I think this continues and I'm really excited about it. So thank you. And I'm looking forward to what's coming this season and I think it's gonna really be a good series of shows.

I. So today, what are we talking about? It's just me. I wanted to open up the season kind of alone just to say thank you and set the stage for the season ahead. And today we are talking about ai. It's here. So now what, how can we evolve? How can we help our teams evolve and what's needed to really.

Help us be comfortable with what's coming because it's here and I think we're going to have to embrace it or be left behind. So the key message is, I think for this show there's pressure to evolve, but there is a way to make sure we're able to handle that and not be feel like we've added stress to ourselves in the midst of already chaos and stress that we feel like we live in on the day to day in our world of clinical operations.

So, as I mentioned, AI isn't here. It isn't coming. It's here, should I say, and from predictive analytics to patient matching, it's undeniable where we're headed. But I think it's important to know that this is a tool and I hear others say it and I believe it too. It's a tool. It isn't here to replace roles.

It isn't here to replace us as people. We will use it as a tool, and I think as leaders in the clinical operations space. We are the ones that will help our teams understand how to learn it and implement it and adapt to it. And so what's really happening today with AI in clinical operations especially in trial design, data and engagement.

I think we should just start to really think about or understand a good question that was posed to me is how are the teams that you engage with using it? And it's all over the map. Some companies I see trying to start using it and implementing it. I see an SOP here and there coming out to help teams.

Know what to do with it or how to incorporate it into the day-to-day. And then I see some other companies not really doing much, it's talked about, but aside from what's within like Microsoft with emails copilot, not much more is being done. And then I see other companies and former colleagues and friends that are in the industry, they're going all in.

And they're bringing in platforms and developing their own company, AI platforms and work streams. And everyone's getting trained. And so it's just all over the map right now, which is understandable because it's new and a adaptation happens at different rates and paces for different organizations.

And that's fair. And so, a couple of ways I think. It's being used. Just example, feasibility for sure. Study startup processes. I'm seeing AI being used to identify sites and the strategy around site selection. How many do we need based on this protocol design and this therapeutic area?

How should we deploy a strategy for site selection and feasibility so that we can be more effective and efficient and not just throw spaghetti at the wall and see where it sticks. And I think that's a really smart way to start. It's small and it helps you get comfortable with the idea of bringing in ai into your processes every day.

I've also seen it being bought into data cleaning processes and remote monitoring tools. Crass are actually coming up with their own for those that are tech savvy. And I think that is something to consider as everyone has different. Capabilities and technology. Some will use it. Some will create their own tools.

Others won't use it at all, and they prefer to stay where they are. And so then you're going to start to bring in different levels of efficiency. And you'll wonder why some crass or some team members are doing things at a faster rate. With more accuracy versus others that don't. And that's the fear that I think many of us have of being phased out.

And no, you won't be phased out, but you do have to get in line with the times, and you do have to learn how to use AI and make it part of your day-to-day so that no one's left behind, and that your work doesn't appear to be less than when it isn't. It's just someone else is using a tool that gets them ahead a little further or faster.

And so. As we begin to incorporate ai, that's why it's so important to standardize what we're doing so one team doesn't get left behind or one individual's work doesn't shine or seem to be better than another's because we didn't standardize how we're using it across the board. And so I think. That's the message here is that making sure we adapt to AI in a standardized way is much better strategy than just leaving it to be and seeing.

Who does what, when, what works. Okay, we'll adapt to that. We won't use this. And the other piece is confidentiality. As a leader, you don't want your teams using AI in a way that you wouldn't approve of if you were aware of it because of your company's proprietary data being out there. This is study plans your protocol design, things that we hold close to us that we don't necessarily want the rest of our community to be aware of.

It's out there if your teams are uploading and copy pasting and putting documents into AI to create their own way. Your data's now out there and how are you handling that? And I've seen SOPs where they touch on this and security and getting approval to use things. And then I've seen a couple SOPs that they don't touch on that at all, and that should be a major consideration.

So. What's really happening today is we're starting to use it, but there's a long runway ahead on how to standardize it, how to make sure our company confidential data and information is secure and that the people behind the tool that are using it day to day are properly trained and they understand and feel comfortable in using it.

That aids the organization in the best way, but also helps them in the day-to-day of their work. And so why doesn't traditional training work right now? Regardless of if it's AI or not, this once a year training situation that we see or you onboard, you do your SOPs, and anytime there's an updated SOP or new SOP, that's when we get training.

But other than that, nope. Just work. Just do our job. And, you know, we may get the opportunity to do a conference through our organization sponsoring us to go but maybe not. And then when we go to a conference, what do we get from that where we can bring that back to our day-to-day and make it benefit the organization and the work that we're doing for the greater good?

It's not working. I over and over and over. I'm talking to the people that are living and breathing clinical operations, whether it's on the site side, the vendor side, the sponsor side, and the training is just inadequate and we continue to try to do this same model and it doesn't work. And yes, we have Veeva and we have these wonderful systems that the companies are great.

Are happy that we have and we can now track our training. But putting a plan in Veeva or a system that's like that, where we can say you've read it and you confirm you understand it, and then it goes over here into a folder and we can print out a certificate for it to say you did it, or a training log to prove that you were trained is not adequate.

That's not study training. That's not ensuring your team is running the trial appropriately. Within GCP, all the things, it just doesn't work. And so how do we find. An ongoing situation of training and professional development that teams can come into and get real time development support. And I think that's a really good question, especially in the age that we're in, where things are changing rapidly with ai, with our regulatory environment, with having to be leaner with the team members and not have as many human resources to get the job done that we've had in the past For whatever the reason economics budget.

Whatever the reason, there's a lot going on in our industry right now and training can't be left to the corner and just hope that. It gets figured out. We have to be strategic and we have to make sure the folks that are doing the work that we task them to do, have the support from a professional development perspective and a subject matter training perspective.

I think that's really important. And so considering curated learning paths AI Skill Bootcamp, soft skill coaching micro learning to help people that are in specific roles really understand how their role. Relates to a training that's been provided. Like these are the things that are important, that are missed over and over from organizational organization, and it is time that we find a solution.

I, I just believe that to my core, and for those of you that follow me people, culture and process is what I preach, and this is totally within that. And so lastly I think it's just important to understand what's most important here. And I say this all the time, trust if our teams don't trust that our leadership is for us and going to support us to be successful in the work that we need to do.

That is at the end of the day for the patients that we're serving. Then we are not gonna get far at all. It doesn't matter how great the training it is, it doesn't matter how great of an AI situation we bring into our organizations. None of that matters if our teams can't trust us. I. To lead them through uncertainty in these times that we're in where we're changing rapidly.

And so I think focusing in not just on the subject matter expertise and the hard skills, but the soft skills and addressing some of the emotional things that are coming up. While teams are in the day-to-day working, such as fear of being replaced by ai, fatigue of continuing to do things the old way, but having to learn how to do things a new way all at the same time, and just resistance.

We know organizational change is not easy and what are we doing to make sure that we are adapting and we're adapting well in a successful way? And so. Am I still relevant, is a question that is raised. I see it all over LinkedIn. It's in my conversations. It's been part of the conferences that I've been part of.

And when I'm speaking or doing a workshop or training, that is something that continues to come up. Am I still relevant? Will I have a job as a CRA in five years? Will I still be able to continue being a project manager? How is this going to evolve? And I think that's an answer we've got to find this ques response to, for the people that are asking it because they need to know in order to be able to continue to do a good job.

And so leading with empathy and clarity isn't optional. We just don't have the option to do that. It's mission critical. And so I think to close out for today, I think the goal and something that we'll focus on, and you'll see a reoccurring theme of throughout. This season is embracing the three Cs culture, clarity and curiosity.

I think embracing those and we will dig into that further as we go into the episodes this season that I'm so excited about. That's what's gonna get us to the next step. Get us down this runway that is pretty long, but. You know, it's step by step, day by day and making sure we have the support the expertise, the collaborations and partnerships that can really help guide us through to the next level of conducting clinical trials.

In the future of trials. It's here really building the foundation for what it will look like to run trials in the next five to 10 years. And so we don't have to have it all figured out today, that's for sure. But we just need to commit to evolving with our teams and evolving as leaders in the organization.

That we are committed to. And so I think I just wanna close out by encouraging everyone don't give up. I think having the community and making sure we're conversating with each other and lifting each other up and supporting each other no matter what your role is the key to all of this. And I'm excited to have you with me for this next season, and I would love for you to share in the comments or send me a message.

Or DM about how AI is impacting you right now and how you're feeling about it and are you optimistic about it? Pessimistic? Do you feel like you don't know where the resources are for you to go? I'd love to hear that. And I'm excited about what's ahead. I will be launching something this year that I think will aid in this, and I'm excited to share that with you in the coming months as well.

So. Have a wonderful day. Looking forward to more episodes this season and it's gonna be a good time. I'm for sure that.

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Melody Keel

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