Behind the Scenes: Meet the clinical research associates
who keep cog trials running smoothly
This is the third installment of a Behind the Scenes series about how Children’s Oncology Group clinical trials work.
The first article focused on how a research idea becomes an actual trial.
The second article focused on the role of COG Protocol and Research Coordinators.
This story highlights the crucial contributions of Clinical Research Associates (CRAs) based at the hospitals, universities, and cancer centers that take part in COG clinical trials.
The first article focused on how a research idea becomes an actual trial.
The second article focused on the role of COG Protocol and Research Coordinators.
This story highlights the crucial contributions of Clinical Research Associates (CRAs) based at the hospitals, universities, and cancer centers that take part in COG clinical trials.
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During her days as a pediatric oncology nurse, it pained Barb Shepperd to see her patients back in the hospital after chemotherapy, sickened by the treatment they needed to beat cancer. She wanted to know more about the medicine she was administering and about the push for better treatments.
“These kids have to live the rest of their lives,” said Barb, now Lead Clinical Research Associate (CRA) at Children’s Hospital Colorado and Chair of COG’s CRA Committee. “We can’t give them these toxic drugs and not worry about the side effects and long-term impact.” One day, a fellow nurse told her about a research study, opening a door that led Barb to spend the next 30+ years playing a central role in more clinical trials than she can count. Barb now manages a team of more than a dozen CRAs and oversees roughly 80 COG trials at her hospital, some with protocols in development, some actively enrolling patients, and some following up with patients years after a trial ends. She is a valued member of the study teams. |
From side job to fast-paced, full-time role
Early on in her CRA career, Barb continued nursing, switching from inpatient to outpatient care while spending most of her time on research. As a CRA assisting the Principal Investigator of a clinical trial, she collected and reported patient data, confirmed compliance with regulatory requirements, served as the hospital’s main point of contact for the study, and more. It’s a big job that requires non-stop multitasking and unwavering attention to detail at every point in time. The integrity of every study depends on it.
“You’re monitoring every patient every single day, making sure everything is correct,” she said. “You’re reading physicians’ notes, nurses’ notes, all other providers’ notes. Severe adverse events are rare, but they do happen. And when they do, it’s the CRA who must pull together the documentation and report it to safety regulators within 24 hours.”
Jenny Lynn Weiland’s career as a CRA began as a side project. She “just fell into” research while working as a medical technologist, testing fluid and tissue samples of pediatric oncology patients.
Early on in her CRA career, Barb continued nursing, switching from inpatient to outpatient care while spending most of her time on research. As a CRA assisting the Principal Investigator of a clinical trial, she collected and reported patient data, confirmed compliance with regulatory requirements, served as the hospital’s main point of contact for the study, and more. It’s a big job that requires non-stop multitasking and unwavering attention to detail at every point in time. The integrity of every study depends on it.
“You’re monitoring every patient every single day, making sure everything is correct,” she said. “You’re reading physicians’ notes, nurses’ notes, all other providers’ notes. Severe adverse events are rare, but they do happen. And when they do, it’s the CRA who must pull together the documentation and report it to safety regulators within 24 hours.”
Jenny Lynn Weiland’s career as a CRA began as a side project. She “just fell into” research while working as a medical technologist, testing fluid and tissue samples of pediatric oncology patients.
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When Jenny and Barb started, there was no formal training program for CRAs. They both learned everything on the job, leaning heavily on COG research operations colleagues for guidance.
“People who end up as CRAs often come from a related healthcare field,” said Jenny, Lead CRA at the University of Wisconsin’s Carbone Cancer Center, who will succeed Barb as Chair of COG’s CRA Committee in January 2026. “And I’ve been surprised at the number of teachers who change careers and become CRAs. What we all have in common is we’re dedicated to helping children and like the idea of advancing research.” |
Barbara J. Shepperd, RN CCRP
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COG’s third-largest group of research professionals
CRAs make up one of the largest groups of professionals within COG, third behind nurses and hematologists/oncologists.
As COG’s Lead CRAs at their institutions, Barb and Jenny manage teams of CRAs. Some focus solely on regulatory compliance, while others specialize in early-phase research, mid-sized studies, or large-scale randomized clinical trials that lead to advances in the standard of care.
At Children’s Hospital Colorado, one of the largest institutions in COG’s network, Barb oversees a team of 10 pediatric oncology CRAs, plus others who research different diseases. Wisconsin’s Carbone Cancer Center, a mid-sized institution, has a staff of six pediatric oncology CRAs. Smaller hospitals often have just one CRA, making it harder to keep pace with the large number of COG clinical trials.
A key part of a more senior CRA’s job is training staff: from newly hired residents and fellows who may be unfamiliar with research, to seasoned doctors, nurses, and pharmacists.
“You have to know what you can and can’t do, what you can and can’t disclose, what samples and data you can and can’t collect,” Barb said.
Another crucial CRA responsibility: verify that every patient enrolled in a trial meets strict eligibility criteria. CRAs double- and triple-check all details, starting before a patient enters a trial, all the way through the end of the study.
“It’s our obligation to do everything in our power to make sure that patients and families follow the protocol to the best of their ability while ensuring the child’s safety,” Barb said.
CRAs make up one of the largest groups of professionals within COG, third behind nurses and hematologists/oncologists.
As COG’s Lead CRAs at their institutions, Barb and Jenny manage teams of CRAs. Some focus solely on regulatory compliance, while others specialize in early-phase research, mid-sized studies, or large-scale randomized clinical trials that lead to advances in the standard of care.
At Children’s Hospital Colorado, one of the largest institutions in COG’s network, Barb oversees a team of 10 pediatric oncology CRAs, plus others who research different diseases. Wisconsin’s Carbone Cancer Center, a mid-sized institution, has a staff of six pediatric oncology CRAs. Smaller hospitals often have just one CRA, making it harder to keep pace with the large number of COG clinical trials.
A key part of a more senior CRA’s job is training staff: from newly hired residents and fellows who may be unfamiliar with research, to seasoned doctors, nurses, and pharmacists.
“You have to know what you can and can’t do, what you can and can’t disclose, what samples and data you can and can’t collect,” Barb said.
Another crucial CRA responsibility: verify that every patient enrolled in a trial meets strict eligibility criteria. CRAs double- and triple-check all details, starting before a patient enters a trial, all the way through the end of the study.
“It’s our obligation to do everything in our power to make sure that patients and families follow the protocol to the best of their ability while ensuring the child’s safety,” Barb said.
Jenny Lynn Weiland, CCRP
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Complex trials drive growing need for CRAs, better training It takes years to run a large clinical trial and years of follow-up to determine the results. Clinical trials have grown increasingly complex over the years, with every study building off the results of another. Regulatory and reporting requirements have also become more numerous and more detailed. “A trial may initially be written to ask a therapy question, but often there are many other specialists on study teams that incorporate questions — radiologists, pathologists, nurses, molecular biologists, radiation oncologists, psychologists, and others,” Jenny noted. |
When researchers make exciting discoveries, they add exploratory questions to follow-up studies. Additional questions require CRAs to gather more data, collect specimens, and administer questionnaires. More studies are including neurocognitive tests that measure how new therapies affect brain functions and other longer-term impacts.
CRAs have demanding jobs, and turnover is high at hospitals, universities, and cancer centers that take part in COG’s federally funded trials. Many CRAs are lured away to higher-paying jobs at pharmaceutical companies or choose to attend graduate or medical school, in part due to their exposure to clinical research. At smaller hospitals with just one CRA, many leave because they want more support and a larger community or to be able to advance further.
“It takes approximately nine months to a year to truly train a CRA for the profession,” Barb said. Yet most training still happens on the job, ad hoc, with CRAs at each participating research site learning different ways to address the same issues.
As leaders in their field and longtime members of COG’s CRA Committee, Barb and Jenny both advocate for more robust training materials in modernized formats to make best practices easier to find, learn, and share. They have helped give more CRAs access to COG’s Fall Group Meetings by adding virtual sessions for those who can’t attend in person.
“We’ve made really good progress,” Barb said, “but we need a better, more comprehensive system for training new CRAs and helping others advance their careers.”
Retaining great CRAs is also a priority for institutions, trying to find ways for them to advance their own careers and knowledge with increasing responsibilities and growth opportunities. Barb and Jenny envision a comprehensive, standardized training program with videos and other resources to help CRAs get the tried-and-true guidance they need to do their jobs efficiently and effectively.
“Improving CRA education and creating more advancement opportunities makes the pediatric oncology research community stronger,” said Douglas S. Hawkins, MD, Children’s Oncology Group. “Barb and Jenny have set the wheels in motion, and the field is better for their efforts.”
When such efforts have been rolled out at the institutional level, enthusiasm and interest builds an excitement about the potential of studies and of research as a career option. People get more invested in the work, and the quality of the work grows.
“If we could find the funding to produce an online platform and keep it up-to-date, it would be wonderful,” Barb said. “Until then, we’ll keep going the extra mile to do everything we can to ensure trials run safely and produce sound results.”
All those extra miles reap game-changing rewards, both for clinical trials and the CRAs whose hard work make them happen. They have seen patients they cared for survive and thrive. They have seen drugs that were once experimental become standard of care.
“When we see investigational drugs that we’ve collected data on and reported on for years move on to become approved by the FDA, it means everything,” Barb said. “It really keeps us going.”