The Humans of the Wyss (HOW) series features members of the Wyss community discussing their work, the influences that shape them as scientists, and their collaborations at the Wyss Institute and beyond.
Any scientist who has ever dreamed of their research helping humans in the real world knows that clinical research is essential for translating their work out of the lab. All clinical research projects have to come through Dionna O. Roberts Williams and her team before they can begin. In her five years at the Wyss, she has seen everything from a soft robotic exosuit that could help the elderly maintain or restore their ability to walk normally to developmental assessment tools for monitoring premature infants as they become toddlers. Learn more about Dionna and her work in this month’s Humans of the Wyss.
What is your position and what does it entail?
As the Associate Director of Clinical Research, I support the Wyss Institute and its collaborating institutions on all aspects of research including investigator-initiated and industry-sponsored studies, as well as a wide range of preclinical and clinical research projects. I am responsible for the oversight and management of a vast research portfolio, specifically related to compliance with “Good Clinical Practice,” federal and university regulations. I am also the Director of the Clinical and Translational Research Core (CTRC). I created the CTRC to establish a platform that provides the Wyss community with pertinent resources to help facilitate both preclinical and clinical research. Through this platform, research teams can find up-to-date information about our clinical research, biosafety, laboratory, and animal services. The CTRC also includes a variety of helpful regulatory standard operating procedures for research teams.
My team, the Clinical Research Team (CRT), manages all research that involves human subjects. All clinical research at the Wyss has to come through my team before it can begin. The CRT provides assistance with study design, protocol development and implementation, coordination, clinical protocol training, data collection, participant enrollment, and maintenance of study documentation and files. Additionally, the CRT completes all protocol submissions, amendments, and annual renewals to the Institutional Review Board (IRB), and assists with the management of study collaborations, including creating Material Transfer Agreements, Data Use Agreements, and Reliance Agreements. Finally, the CRT assists with Non-Human Subjects Research protocol creation and Committee on Microbiological Safety (COMS) submissions, amendments, renewals, and coordination.
How does the clinical research team help to facilitate the translation of Wyss research into technologies that benefit the end-users?
Between our diagnostics, therapeutics, and medical device focus areas, the Wyss Institute has vast ongoing clinical research efforts, with more than 80 human subject studies to date and 23 that are currently active. The CRT is the central liaison between study personnel, study participants, and the IRB. Researchers come to us with their ideas and we suggest ways they can approach their project. Prior to the initiation of clinical studies, we work with researchers to write their study protocol, which contains all of the steps that the research team must follow while conducting their work in order to comply with IRB regulations.
Multiple iterations of the protocol go back and forth between my team and the research team before it is finalized and ready for submission. We also compile and create other study-related materials, such as case report forms, recruitment materials, and informed consent documents. Finally, we submit the project to the IRB for review. The IRB may come back with questions to clarify aspects of the protocol before it ultimately receives approval. Only then can the researchers begin their work. This is how the IRB ensures we are keeping participants safe.
The CRT also supports the administrative aspects of the preclinical work at the Wyss Institute, which occurs prior to human subject testing and usually consists of cell and animal work. For preclinical work, I help to maintain compliance by submitting the protocols and essential paperwork to the appropriate governing agencies and sponsors. I work closely with the Wyss Veterinarian on animal studies and with the Wyss Biosafety Officer on our microbiological studies. Together with our clinical studies, all of these capabilities are a driving force for the successful translation of research and laboratory innovations at the Wyss.
What are some of the projects you’ve worked on?
The CRT is active on many projects at the Wyss. We have helped to initiate multiple projects from a research administration and compliance standpoint, like the Flexi-mitts study with Eugene Goldfield, the Neurorehabilitation study with Conor Walsh, and the THoR project with Donald Ingber. We have also facilitated the completion of projects, like Michael Super’s Sepsis Blood Draw work and Eugene Goldfield’s Multi-Robot Part I and II projects. My team enrolls, screens, and schedules participants, obtains medical clearance for participants, organizes participant transportation, is responsible for participant compensation for donating their time, and audits protocols – the list goes on and on. We’re just a small team of four – Lauren Bizarro, Sarah Sullivan, Jack Eiel, and myself – but we make a big impact.
How does your work help solve real-world problems?
As research administrators, we play an integral part in solving practical problems. We write the research protocols that aim to investigate and answer critical research questions that may help to solve real-world problems, like helping people regain mobility after a stroke or understanding pathogenic tolerance. We train study team members on their protocols to ensure regulatory compliance for successful protocol completion and we oversee the studies for research compliance at federal, state, local, and university levels.
You had already been working remotely prior to COVID-19. So, did the pandemic affect your work?
The COVID-19 transition temporarily doubled my workload, as the Wyss received multiple mission critical awards that required several time-sensitive submissions to the appropriate regulatory bodies. These submissions needed to happen as quickly as possible in order for the research teams to begin work, and obtaining approvals involve a lot of moving parts. Simultaneously, daycare closed down, and having my one- and three-year-old sons home made the timely execution of these projects’ submissions even more challenging and stressful. Thankfully, things have calmed down a bit and the boys are back at daycare now.
It has also been an adjustment period for my team being at home. I’ve been working remotely since August 2017 when I moved to North Carolina. I’ve had three years to hone remote working skills, like maintaining a work-life balance that prevents me from responding to emails at all hours of the night, and identifying aspects of my work environment that make me more focused and productive, like having a designated work space set up at home the way that it would be on-site. While my team was used to communicating with me via Zoom, email, phone, or text, for them it was a change because they were used to coming into the office and being together. Luckily, we have a great team environment and have built a nice rapport with each other, so our communication has never really faltered. It’s essentially like we’re still together, even though we’re not physically together.
Thinking back, what inspired you to get into this field?
During my junior year of college, I was a selected National Institutes of Health Summer Scholar, National Institute on Drug Abuse branch, working with the Epidemiology and Prevention Research Group at Washington University School of Medicine in St. Louis under the direction of Dr. Linda Cottler. That summer I fell in love with the idea that through clinical research, I could help facilitate projects that could benefit entire populations of people. So, I decided to pursue a career in clinical research.
What continues to motivate you?
My main motivation for working in clinical research and regulatory compliance is knowing that the work we do has the potential to benefit the lives of so many, especially members of vulnerable populations. This is particularly true at the Wyss, where we constantly witness our technologies making their way out of the lab and into society. I’m inspired to work alongside our investigators – helping them navigate complex research regulations with the goal of conducting ethical and compliant research effortlessly.
What are some of the challenges that you face?
The work at the Wyss is completely novel. The novel aspects of our work do not always “fit perfectly” into regulatory requirements, which can be challenging at times. But like most things at the Wyss, we’re breaking the mold and creating something new, not just through our disruptive research endeavors, but also through the customized protocols required to support these efforts.
How have your previous professional experiences shaped your approach to your work today?
Though I’ve always worked in the field of clinical research, I’ve done so many different things. I’ve been a research coordinator, where I met with participants, obtained their consent, conducted interviews, and collected all of the data. I’ve also been the graduate student conducting and publishing my own research. I’ve been a clinical trials manager, where I was in charge of phase 2 and phase 3 studies, one with 27 sites nationally and internationally. I traveled all over the United States and Europe to manage these projects and audit and collect data, working with 27 nationally and internationally known Principal Investigators (PIs). In these positions, I mentored high school students and medical students. I also worked closely with my PI to write and submit grants, complete budget justifications and timelines, meet milestones, complete and submit Food and Drug Administration Investigational New Drug Applications and progress reports, and to write letters of recommendation for faculty promotion. This diverse clinical research background has prepared me to manage all phases of research in a fast-paced environment like the Wyss. I have a strong understanding of what teams around me are doing and the necessary collegial skills that allow for successful working relationships toward the shared mission of disruptive, translational innovation.
When not working, how do you like to spend your time?
Outside of work, I spend time with my husband, Brandon, and my sons, Langston and Ellison. We love going on vacations and spending time on the beach. When I am not with my family and friends, I spend my time quilting. I am an avid Quilter and love creating a variety of custom quilts, bags, purses, and wallets.
If you had to choose an entirely different career path, what would it be?
I would pursue a career in health law. Throughout my clinical research career, I have seen firsthand how health disparities disproportionately affect communities of color and individuals living with chronic illness and disabilities. Historically, vulnerable populations experience differences in health care treatment and access to care. For example, the literature shows that the morbidity and mortality rates in Black pregnant women are significantly higher compared to their white counterparts. A Black woman’s ability to pay and education level do not seem to matter. Therefore, I’d use my career in health law to help create change in these areas. I’d work to break down barriers and increase access to health care in vulnerable populations. I’d want to create more awareness and policy around health disparity issues, including diversity and inherent and implicit bias training for health professionals.
What does it feel like to be contributing to the development of cutting-edge technology that has the potential to have a real and significant impact on people’s lives and society?
The novel technology development and the transition from bench to bedside is the most exciting aspect of my work. It feels amazing to know that the work I’m a part of can potentially benefit groups of people nationally and internationally. Being a part of the Wyss infrastructure by helping to develop and facilitate the translation of these technologies is incredible.