There are many different players in the clinical trial journey, from the participant, to the researcher, to the sponsor, and more. But do you know about the study coordinator? Study coordinators play an integral role in the clinical trial process, assisting participants with various tasks and guiding them throughout their journeys at the same time that they gather data for the principal investigator and sponsor. To learn more about what they do, we were thrilled to sit down with Kelly Roberts.
Kelly Roberts is a Clinical Research Coordinator in a private gastrointestinal practice in Western North Carolina. Kelly, a Registered Nurse, specializes in IBD; Crohn’s and Ulcerative Colitis. Kelly attended the University of Alabama in Birmingham and received her nursing degree at Pasco Hernando Community College. Kelly always puts the patient first and ensures that they feel heard, understood, and comfortable throughout their entire journey - even after the clinical trial comes to an end. Read our full conversation below.
Interviewer: Tell me a bit about your research site.
Kelly: Research sites come in all shapes and sizes. You can find research sites in hospitals, large practices, or free-standing sites, where all they do is research. Our research department is located within a large clinic and is an appendage of the largest gastrointestinal (GI) practice in Western North Carolina. We have multiple physicians, practitioners, and study coordinators to cover all our active trials. Our participants travel from Tennessee, Georgia, South Carolina, and North Carolina, all to come to our practice.
Interviewer: What is your typical day like?
Kelly: We start our day gathering data. We retrieve lab results and check for voicemails in the morning, review them, and we see who needs what where, why, and how. We triage what needs to be done first, such as safety labs, new orders, quick scheduling of transportation for a participant, or liaising between the clinical trial participant and investigator regarding a medication change.
Next, we move to participant visits. When we see a participant for a visit, we gather and process the specimen, review it with the investigator, and upload the data to a secure electronic data capture (EDC) system. This helps the sponsor evaluate how their trial is progressing.
Last but not least, we complete all of the regulatory paperwork, which needs to be timely and meticulously maintained to be sure we are always inspection-ready to comply with the FDA and requirements for participant safety. This includes reviewing new information on the trial and distributing it so that the participants have the most up-to-date information.
I’d say that 20% of my day is filled with participant-related tasks and 80% is filled with regulatory tasks. My favorite part is working with the participants.
When you’re a study coordinator, there are many hats in the air. The assumption might be that coordinators would just focus on seeing participants all day, but there are so many tasks to complete, from collecting data, to coordinating medications, to filling out paperwork, and more, so each day is filled with many tasks that are quite varied.
Interviewer: When do you typically share the idea of a clinical trial with patients in your clinic?
Kelly: Since we work in such a large clinic, the physicians and investigators work with patients downstairs and clinical research is done upstairs. Usually, when a physician is seeing a patient for the first time and they think that they may be a candidate for a trial, the physician will ask us to come downstairs to introduce ourselves. Another way that we are introduced to patients is when they have been a part of our practice for years and now have a new diagnosis.
Once we introduce ourselves, we may give the patient informed consent or IRB-approved literature so that they can read more about their disease and the research process. Sometimes, it’s the first time that the patient has been acquainted with the disease.
In our practice, a lot of the diseases that we research aren’t curable; they’re something we manage. It’s a bit overwhelming for patients to learn that they have an incurable condition that they have to manage for the rest of their life, so it’s important that we let them know that they have a resource at our clinic. We give cards with our contact information to the patients when we introduce ourselves, so whenever they decide they’d like to learn more about the clinical trial, they already know our names, faces, and how to reach us. It adds familiarity to the process and helps patients feel more comfortable.
We’re lucky in that we are part of a large practice. We get to be hands-on with the patients and can interact with our physicians on a daily basis.
Interviewer: Tell me about how you do the informed consent process at your research site.
Kelly: We often call informed consent the backbone of our trial. Once patients are interested in learning more about a trial, we provide them with the informed consent form, which can be picked up in our office or mailed to their home. I call them to ensure they received it and encourage them to not sign it just yet. Rather, I recommend that they highlight the document and put sticky notes on anything that they’d like explained in more detail. The informed consent form is a catalyst for conversation. The patient can make notes and ask questions so that when we go through it together, taking the time to get their questions answered..
Before we schedule a time for them to come in to meet the study coordinator and physician, we look at their chart to see if there’s a glaring reason why they wouldn’t be able to participate in the trial (i.e., if they didn’t meet the inclusion criteria). If that happens, we let the physician know that they didn’t meet the criteria or we direct them to another clinical trial that they’d be eligible to participate in.
Once we determine they meet the study’s entry criteria, we schedule time for the patient to meet with the study coordinator and physician to review the trial. We take them to a private room, review the informed consent page by page, and ask them to share their questions with the coordinator and principal investigator. We also encourage patients to bring a loved one with them, like a parent, child, or partner, because they might have additional questions that could be helpful to consider.
If the patient wants to proceed, they can sign the informed consent form at that point, and the study coordinator or investigator will sign as well.
It’s important to remember that informed consent doesn’t stop once the patient signs; it’s an ongoing process. We recommend that participants keep the document in a safe place so that they can use it as a tool and refer to it if they have questions along the way.
Also, participating in a clinical trial is always voluntary. Just because you say yes today doesn’t mean that you can’t decide it’s not right for you later on. A clinical trial may be a good fit, but is not your only option.
Interviewer: As the study coordinator, what is your interaction like with patients once they are participants in a trial?
Kelly: I become the person who holds their hand, their sounding board, their voice–really anything that supports them with their disease state. The participants have my number in their phones and I tell them that they can call me at any given time. If they somehow reach my voicemail, we return their calls within an hour. We want to give them a personal experience.
Be it two months, six months, or six years, we’re partners, and we navigate this journey together.
Interviewer: What do participants tell you about their clinical trial experience upon completion of a trial?
Kelly: Once they’re done with a trial, they know that it’s not a scary process. I get referrals from previous participants and calls from some saying things like, “My brother has Crohn’s. Can I have him call you?”
Participants feel empowered and confident to educate their family members and/or members of their community about clinical trials. They feel good that they’ve maybe helped someone else through the research. They get a global picture of what they have contributed.