Inside the World of Clinical Research Project Management with ACRPM

Jess Thompson shares her journey in clinical research project management, shedding light on the mission of the Association of Clinical Research Project Managers (ACRPM) and its global support for professionals in the field.

Jess outlines key aspects that research sites and the industry need to understand about clinical research project management and its impact on fostering innovation and excellence in healthcare practices. 

Transcript

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Jimmy Bechtel 0:01

Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks allows our partners and those that we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, and learn more about our community. Today, we have Jess Thompson, the founder and CEO of the Association of Clinical Research Project Managers here to share with us, What the association does, what their purpose is and how they help clinical research sites better serve their patients. Jess, it's wonderful to have you. We're really excited to learn more about ACR PM. If you wouldn't mind, we'd love to hear first a little bit more about you.

Jess Thompson 0:48

Absolutely. Thank you guys so much for having me today and allowing me to talk about my passion and clinical research project management and kind of hopefully Debunk the myth of clinical research project managers in our industry. So my name is Jess Thompson. I am the founder and CEO of the association of clinical research project managers. I'll be referring to as ACR PM going forward. My background started in a lab processing samples for clinical research projects. And then I moved more into the clinical research coordinator role. From there, I moved into regulatory management still at the site side and then into more project management still on the site side as well. All of these at academic medical centers. I have also worked at a standalone site as well. So, I kind of know the ins and outs of the different levels and the different struggles at these clinical at the clinical research sites. From there, I moved to CRO world as a clinical trial manager, and then over to the sponsor side as a country trials manager across all of this. I saw a very similar theme in the lack of training as you kind of move up the ladder in clinical research and a lot of trends in. Being unable to establish project timelines and project budgets and really just managing the project using tools and techniques that are available for you. But most people have no idea. They are available. So a little bit of a background on how I even moved from the clinical research coordinator role into more of a project manager role. I was a very eager clinical research coordinator at a site and I had a project manager who was emailing me. And so I thought a very eager self. I was like, let me Google what a project manager is and because that's what I want to be when I grew up. And to my surprise, it said somebody that manages projects. And I was like, okay. What does that mean? What's a project? And to my shock, it was the definition was anything that has a beginning and end and specific objectives to meet. So I thought, why aren't we considering clinical research projects or clinical research studies as projects? Because we are all managing these. studies and they have a beginning and end and specific objectives to meet. So from there started my journey of becoming a clinical research project manager. I then started doing more training and understanding what really is that role and to my shock I realized that as a coordinator I was an accidental project manager and from there started introducing more project management techniques and tools into my daily work and then sharing the knowledge that I learned with The other individuals in my at the site that I worked at, and then continuing to do so throughout my career. And I've really learned that this is kind of my passion of really being able to train project managers and accidental project managers on tools and techniques that will just make their lives easier and help them deliver projects more efficiently and effectively. That's

Jimmy Bechtel 3:53

great, Jess. So excited to hear about your background. Really great that you have that complete picture, right? Coming from the site, I think there's a lot of dynamics that are hard to understand with clinical research unless you've been in that role. So awesome. Thank you for sharing with that. So can you then move a little bit into sharing? With us an overview of ACR PM and its mission to support clinical research project managers worldwide.

Jess Thompson 4:21

Absolutely. So ACR PM was established to provide a space for clinical research professionals to grow not only professionally, but also personally. Because I believe it's important to really recognize that success depends on a very balanced approach to both work and personal lives. So the 3 main themes that you'll see across AC RPM and that I really tried to remain focused on are connecting our members and really building a, an environment for collaboration and connection and teamwork as well as communication, because project management and the majority of our industry really relies upon. Very strong communication skills. With that also providing education on project management methodologies and tools and providing templates so that you're not starting from scratch. Because what I learned as I learned more about project management was that we were really reinventing the wheel in most of the projects that I was a part of. So I began building templates and really seeking out tools and techniques that would make us more effective and efficient, but also. Allowing more collaboration because we all understood what we were doing and kind of following the same route when we were managing studies. And then finally, really looking at clinical research professionals as a whole person, not just a productivity engine. I feel like many of us, as we've seen the industry shift we've timelines reduced and budgets reduced and that really weighs heavy on the clinical research professionals on all levels. So, really taking into consideration and. Speaking about the mental health and the physical health aspects of our, our clinical research professionals talking about burnout and mental health issues and really trying to make these topics less taboo and you know, taking care of the whole individual, not just focusing on efficiency and effectiveness.

Jimmy Bechtel 6:15

That's great, Jess. It's really exciting to hear that it's, it's more than just. What meets the eye or what you might think of when it comes to clinical research project manager upbringing. It's that total package. It's, it's making sure that they're a rounded individual. And I think that's essential to our workforce today. You mentioned things like burnout and how we prevent that. So thank you for bringing and highlighting those those individual aspects to what your mission is and what you do. And when it comes to bringing those individuals into that aspect of our workforce, Absolutely. So as we all know here, everyone in clinical research and the clinical research process is really essential for advancing medical knowledge and patient care. It's cruxical to what we do to bring new medicines to patients. So how does clinical research project management contribute to the success of those projects? And I guess maybe relate it back to what it's. Critical components, clinical research, project management plays in bringing those medicines to patients.

Jess Thompson 7:23

Absolutely. So the more I learned about project management, the more I was shocked about how in the clinical research industry, we really don't talk about the how to, we really, we know. A lot about what, like the FDA will release guidance is and, you know, others will release guidance is in the NIH and understanding GCP. There's really guidance is, but the how to is really dependent upon the organization and the individual. There's not really a set of this is how you run a clinical trial. This is how you manage a study. So I found that really interesting because across other industries, product management is so preached upon and built upon and you. Typically have project managers who are trained in project management and the ability to, you know, adapt and manage these projects in their very specific industries for clinical research. We really don't do that. 1 of the myths that I'm really. Is that project management is only at the very high level of, you know, portfolio management. So, all the studies that are under one drug class or one drug specifically or at the sponsor level, or even at the Sierra level if we look at it. Projects are exactly what we said earlier, have a beginning and end and specific objectives to meet. So each of our sites have a beginning and end and specific objectives to meet for their projects. So whoever's leading that project at the site level. It's also a project manager. It may not be at the same level as what the CRO or the sponsor is managing, but they are managing that project and they are utilizing the same techniques and tools that other project quote unquote project managers are using on the study. So talking about and understanding training on project management is essential, not only at these higher levels, but down to the site level as well, where we're having our coordinators and our PIs and our sub eyes regulatory understanding, you know, things like how to build timelines, how to manage the timelines what to do if a project gets off track and what you need to do to get it back on track understanding what scope creep is and how to handle scope creep, which To be honest with protocol amendments, that is the heart and soul of scope creep in our industry how to manage stakeholders, how to identify risks and manage risks and then some higher level techniques like communication skills, time management skills, and then finally, lessons learned because we. As an industry don't really take the time to look back on the positives and negatives of what occurred on a clinical trial to then put forward into the next study. So a lot of the training that I do is built around these very high level things that. They're not hard, hard ideas to grasp. It's just that we don't talk about them. We don't take the time to plan for a project. We don't take the time to debrief after a project, but really, as soon as we get done with the project, we're moving on to the next 1, but a famous quote by Ben Franklin is sorry. Failing to plan is planning to fail, and in my opinion, we do not take enough time in the planning stage to really identify what our risks are, what objectives we need. We want to meet what we need to capture. And this is really causing our industry to. Spend a lot of money on protocol amendments and timelines because timelines aren't being built accurately. So we have to admin the timeline or they take longer than what is expected because timelines are kind of just thrown out there. Willy nilly instead of really building timelines based on like the project management science that. The project management institute has really developed and strengthened over the years. So I know that's kind of a long winded answer, but just to say that clinical research project management can really contribute to the bottom line. Because we're, if we're able to plan and conduct and manage and then close out projects properly, we'll be able to stay on time and. Using accurate timelines and budgets, and then also again, maintaining the sanity of our workers, because we are such an industry where it's go, go, go if we are able to introduce tools and templates and methodologies that exist without having to reinvent the wheel, we'll be able to, you know, decrease the stress. Be able to communicate more effectively and really be able to utilize lessons learned moving forward for other projects.

Jimmy Bechtel 11:54

There's some great tidbits in there. Just for sure. What I really liked was the fact that you mentioned around how we don't often approach. Our clinical trial execution at either the sponsor and zero level or really at the site level to understand that full circle of executing it right. We oftentimes start complete and then move on to the next. And we don't take those necessary steps to analyze and understand what we need to do differently next time. It's really a problem in the industry. We see it a lot. We don't see enough improvement. Trial over trial at the site or at the sponsor and CRO level or even at the professional service provider level in what it means to iterate on and improve for the next time. What kinds of lessons can we take out of here? And what should we do next time? I think is a essential. Aspect of doing project management well and a valuable lesson. I think that's probably a very important aspect of what you had mentioned and what your organization does. So thank you for mentioning that. I think it goes to underlie the value in what your association and organization bring to the table with bringing up those clinical research project managers.

Jess Thompson 13:08

Absolutely, and you also bring up a good point, because I feel like we are all still so siloed in our industry where it's sites, zeros, sponsors, vendors, but we don't collaborate. And I think that the collaboration is what we are really missing. Because typically in project management, we don't collaborate. Whenever you're looking at the whole picture of the project, you're bringing in the experts from each of these individuals and the individuals who are doing the work to really create a work breakdown structure in order to identify you know, the correct timeline and an accurate timeline and an accurate budget where in our industry, that's typically done at a very high level without involving those experts at the site level. And, the sites are really the ones that we rely upon to do the work of the study, to get the data, to get the patients in. So by not having them as a collaborative effort when building these timelines and even the protocol in some aspects by looking at the schedule of activities without involving them, we're really doing ourselves an injustice and costing the industry a lot of money and failures for timelines and even failures for studies because just a study may not be set up in a way that is able to actually run the study.

Jimmy Bechtel 14:23

That's exactly right. I think there's a lot to learn from that process. And, and something to take back to our organizations. We need to figure out how to do that really, really well. And it's great to hear that there's organizations like yours that can help people learn how to do that really, really well and really effectively. But I want to focus again on that theme that you had mentioned, collaboration and connection, because I know that they're also. Key themes of the work at a CRPM. Can you share some examples of collaborations that you've done and maybe how some of those in efforts might have impacted or grown your organization and your your members?

Jess Thompson 15:00

Absolutely. So from the beginning, my focus has really been on collaboration and not competition. My goal is to really. Build that bridge between clinical research and project management that doesn't currently exist. Other organizations are so good. I mean, you all as as our as CRS. I'm sorry. As CRS is so good about identifying what's going on at the site level and what the concerns are at the site level. SOCRA, really great at, you know, the clinical research side of things. It was a CRP, you know, all of these different organizations are so good at their current niche that. The niche of clinical research project management is not really being focused on, but there is a project management Institute that focuses on project management for other industries. So, build bridging that gap is really my focus and identifying. What organizations that I can help build a relationship with to provide that training for their end of their members. So, coordinators, data managers, regulatory coordinators series are all performing some type of project management activities in order to get the projects completed so they could benefit from the even basic project management training. So, not getting into, like, the really nitty gritty things, but more high level. You know, communication, stakeholder management timelines, all of those kind of things that we can really discuss at their level because they are accidental project managers. So, you know, working with various organizations and clinical research to provide that training and then even templates as well. Working with project management Institute to help build bridge that gap. I also speak at conferences talking about clinical research, project management you know, doing different training sessions and working with minority groups to present to their members as well. Because again, project management is, I feel like, is a very unique. Set of tools and techniques and methodologies that impact so much of our industry, but it's not really recognized. So really just trying to build that bridge between CRO sponsors sites and the different organizations to say, okay, we're not here for competition. We're here for collaboration to really move this industry forward together.

Jimmy Bechtel 17:21

That's excellent and a really good example of how important and how valuable that can be for cross institution collaboration and what that really means from an outcome perspective for those that are participating and really able to execute this process well. So thank you for for sharing that. So Jess. As we begin to wrap things up here, what should research sites and the industry as a whole know about clinical research project management? And how can they maybe then get involved to learn a little bit more about your work and what you all do?

Jess Thompson 17:55

So I think the main goal of this whole conversation, if you take nothing else away, please just take away the idea that project management is not just at the sponsor or CRO level. Most of you guys listening to this podcast are probably performing project management activities and are. Accidental project managers. So I encourage you to start looking into project management tools and techniques and methodologies and seeing what parts of your life that you're reinventing the wheel on that. You know, there may be a methodology or a template out there that could really help you make your life a little easier. And just to say also that, you know, Providing project management training for site staff and other individuals working on clinical trials. We can cut project costs. We can decrease protocol amendments, and we can deliver these quality projects using realistic timelines and budgets. So, by providing training, that is really. Almost soft skill training in a lot of situations, but providing training to our to our research staff can really help the bottom line and really help move clinical research forward by learning from the the things that didn't work in the past and just making sure that we're managing our trials in a way that is bringing them to market by bringing in all the important individuals in the study and being more cohesive and collaborative.

Jimmy Bechtel 19:19

Excellent, Jess. I think that's a really wonderful place for us to end our conversation on. Thank you for sharing about ACRPM, about your mission, about what you're doing, and about how important clinical research project managers are in our industry and the types of skills and knowledge they bring to executing. Which was rightly acted as clinical research projects. Our trials truly are clinical research projects, no matter how you look at them from the site side or the sponsor CRO side. So again, thank you for being with us today. And thank you for sharing a little bit more about you and your organization.

Jess Thompson 19:55

Thank you so much for having me and I look forward to. Talking to you guys more about project management.

Jimmy Bechtel 20:02

Sounds good. Well, for everyone that's listening, make sure that you register for our upcoming Site Solution Summits being held throughout the year by visiting the Summit page on our website, myscrs. org. While you're on our website, be sure to also check out other SCRS publications and resources made for our community in those sections of our website. As well. We appreciate your listening to today's program and look forward to having you join us for more great content in the future. Thanks again for listening.