In recognition of National Nurses Week, we interviewed Sadie Samson, a Mednet Project Manager who is also a nurse. Sadie was a client before joining the Mednet team. She brings a unique perspective and a wealth of relevant experience to her clients’ projects, along with the understanding of the critical role of nurses in clinical research.
Please describe your previous clinical trial and broader healthcare experience.
I began my research career as a Clinical Research Coordinator at a local research organization. The organization was affiliated with a large cardiovascular institute that included the research site, a CRO, and an imaging core laboratory. While there, I quickly moved into Investigational Site Research Management and held additional roles, including Manager of Continuing Medical Education (CME)/Continuing Nursing Education (CE), and Coordination of an Advanced Heart and Vascular Fellowship Program. I was responsible for managing local site coordinators and local research trials, creating and maintaining site contracts and budgets, managing all CME/CE activities and their respective accreditations, and then managing physician applications, payments, scheduling, grant submission/management, and industry funding/relations for the fellowship program.
My growing responsibilities exposed me to many different aspects of clinical research. This is also where I started working with Mednet as a client and a user.
What is your current role at Mednet?
I am a Project Manager III and have been with Mednet for just over two years. I collaborate with clients on study builds, provide ongoing client support by troubleshooting questions and changes, and support study designers using Mednet.
How does your role impact/improve clinical trials for Mednet customers?
I believe that the variety of all my experiences impacts how I work with clients, look at a protocol and CRFs, and plan study builds. I bring a clinical and site perspective to the table, which helps me relate directly to the client and their sites. I have also worked very closely with various physicians/providers to navigate different EDC systems. I understand the site responsibilities and the Investigator’s responsibilities for data entry, reviews, and approvals.
How do you apply your previous / broader career experience (particularly your experience as an RN) to your role at Mednet?
I love being a nurse and enjoy using my knowledge and experiences to aid patients, colleagues, and clients comprehend the study content. My background is in Cardiovascular Nursing, Research, and Education. However, knowing the Cardiovascular patient means that you also know comorbidities, such as diabetes, vascular, and respiratory disease. Nursing has taught me to assess, gather information, document, and plan appropriate care. This approach applies to building a study within Mednet. I assess the new study, gather information from the client, document the study build process, and then plan out the project with the client. I also understand a broad range of medical terminology, disease states, diagnostic testing, and treatment strategies, which directly aid in understanding different research protocols, case report forms, and data management needs.
To date, what has been your most exciting project at Mednet?
My most exciting projects have been client projects. I get to meet and work with new clients, challenge myself by learning new protocols, and learn the ins and outs of their specific study. I also get to lean on my educational background and teach new clients about Mednet and the functionality that may be beneficial for their studies.
Given your prior experience and your current role, what do you see as the biggest challenges – or opportunities – in clinical trials?
There is a significant opportunity around education. I see a vast knowledge disparity regarding the public and their view of clinical trials. Clinical trials started with a rather tumultuous beginning, and still today, many patients have a negative view. It is essential to acknowledge the past and show how it paved the way for future and current generations. It’s also crucial to ensure that the general public is aware that there are strict regulations in place to protect the patient, such as Good Clinical Practices (GCPs) and FDA Federal Regulations, which stipulate that the “rights, safety, and well-being of the patients are the most important consideration and should prevail over interests of science and society.” Knowledge is power, and ongoing education represents a significant opportunity to keep patients engaged, involved, and empowered to make independent and confident decisions regarding their participation.
Do you see any notable trends across the clients you serve?
Yes, patient-reported outcomes are becoming increasingly important for many clients. Subjective data such as the patient’s symptoms, frequency of symptoms, the impact of the disease/condition on daily life, and perception of the disease/condition and treatment over time are not attainable by reviewing objective data. This data can only be obtained from the patient, which is extremely important in clinical research. Patient-reported outcomes are documented in various ways; however, I often see them collected through surveys, questionnaires, and diaries.
What aspects of the clinical trial industry do you find most interesting?
The clinical trial industry has many fascinating elements; however, the most amazing are the research patients themselves. Clinical trial participation is entirely voluntary, with no promise of direct benefit, for the patient involved. In my experience working directly with the patients, I have noted that most research patients participate to help future generations, like their children or grandchildren. I am completely humbled and inspired by personal stories of wins and losses and the reasons why patients choose to participate.
How do you see the role of technology impacting clinical trials?
Technology will always play an important role, directly impacting clinical trials. It is incredible how much data can be stored in an electronic system. However, I see that technology will also need to keep up with new and innovative ways to document patient-reported outcomes since the patient is the source of information and not the clinical team. Data entry must be easily navigable for patients of all ages so that data can be entered and submitted quickly and accurately by the subject.
What do you view as the value and/or most significant opportunity for the role of RNs in clinical research?
As a Nurse, I bring a strong presence to clinical research. I am a positive resource and liaison between the physician, patient, and Industry Sponsors. I can comprehend specific research studies, complex designs, and requirements and provide appropriate education to the patients and other providers. I can also understand and navigate protocols and case report forms, so they are built appropriately in iMednet. Sadie exemplifies the level of industry experience the Mednet team brings to each client engagement. Her nursing background adds layers of deep domain knowledge and a unique understanding of the patient experience that adds significant value for our clients. We recognize Sadie during Nurses Week and every week for her continuing contributions to clinical research.