What Clinical Research Really Looks Like: Insights from Senior CRA Keidy Jacobs

From breakthroughs in cancer therapies to innovative treatments for rare genetic disorders, the foundation of modern medicine is built upon clinical trials. These thorough, regulated studies explore new medications, medical devices, and interventions through human participation. Clinical research is an essential force in advancing medical science, transforming promising concepts into verified therapies that empower healthcare professionals to make informed decisions that ultimately save lives. Despite its critical role in enhancing public health, the realm of clinical research is often clouded by misunderstandings.

Challenges such as misinformation, public skepticism, and transparency issues hinder trust in clinical trials. This disconnect became particularly evident during the COVID-19 pandemic, wherein skepticism regarding vaccines and treatments overshadowed years of scientific achievement. However, behind each trial is a dedicated team of professionals committed to ensuring that safety, ethics, and precision are observed during every step of the process. One key figure in this effort is the Clinical Research Associate (CRA), whose role is vital yet frequently unrecognized.

To delve deeper into what happens behind the curves of clinical trials and why understanding these roles is essential now more than ever, we engaged with Keidy Jacobs, a Senior Clinical Research Associate at Syneos Health. With over a decade of experience monitoring complex multinational trials covering oncology, autoimmune disorders, neurology, and rare conditions, Jacobs has become a seasoned expert and a passionate advocate for transparency, inclusivity, and mentorship in research.

The Unseen Custodians of Clinical Truth

Jacobs transitioned into clinical research from socioeconomic research, primarily focusing on statistical analysis. “The switch was a natural progression,” she notes. “In clinical trials, my analytical background aligns perfectly, where accuracy, data integrity, and interpretation are indispensable. However, I never anticipated the human aspects of this job would resonate so deeply with me.”

As a CRA, Jacobs does not interface directly with trial participants. Instead, her focus is on reviewing medical histories, verifying data, ensuring compliance with Good Clinical Practice (GCP), and confirming adherence to trial protocols. “Every medication dose, lab result, and adverse event documentation must be meticulously checked,” Jacobs emphasizes. “This role transcends mere administrative tasks; it ensures that the data truly conveys the experience of the participants.”

Jacobs highlights the CRA as a critical link between the clinical trial site and the sponsor, responsible for filtering information and resolving problems efficiently. “We identify, escalate, and address pivotal challenges,” she explains. “We also protect study teams from being overwhelmed with extraneous details, allowing them to concentrate on patient care and data integrity.”

A Conversation with Keidy Jacobs: Challenges, Truths, and the Future of Research

Q: What do you see as the most pressing challenges in clinical research today?

Jacobs: The most significant challenge we face is trust—or rather, the absence of it. Public skepticism surrounding pharmaceutical companies and clinical trials acts as a barrier to participation, which inevitably hampers progress. If people lack understanding of how studies operate, they are reluctant to engage. This stagnation leads to a domino effect. Promising treatments remain stalled, patients miss opportunities, and healthcare systems incur unnecessary costs.

Q: Why do you think the CRA role is misunderstood, despite its importance?

Jacobs: Our work often unfolds behind the scenes. We don’t prescribe medication or design studies, nor do we meet patients directly. However, we serve as the final checkpoint, ensuring that reported data is ethical, accurate, and reflective of the actual trial experiences. Many envision clinical research as involving lab coats and microscopes, while in reality, it represents a collaborative team effort.

Q: How can the industry combat public mistrust and misinformation?

Jacobs: The solution lies in increasing transparency and education. We need to clarify what clinical research is—and what it isn’t. These trials undergo rigorous layers of regulatory oversight, ethics review, and safety assessments before any participants are enrolled. The majority of professionals in this field are genuinely dedicated to ethical practices. I’ve witnessed firsthand the positive impact that careful monitoring can yield.

Q: What changes could help make clinical trials more inclusive and accessible?

Jacobs: Diversity is crucial. Trial participants must reflect the communities these therapies intend to serve. We also need improved funding mechanisms and regulatory frameworks to ensure that treatments remain affordable post-approval. Education is essential too, particularly in underserved regions, to raise awareness about ongoing trials and to clarify their purpose and processes.

Q: You actively mentor new CRAs. Why is this vital to you?

Jacobs: Mentorship cultivates internal trust and enhances trial quality. I’ve developed CRA shadowing initiatives and tools to assist site teams in optimizing their performance. When team members feel empowered and supported, they are more likely to identify issues early, resolve them swiftly, and maintain research excellence.

Making Science Human Again

For Jacobs, the clinical monitoring role intertwines technical expertise with a deeply human perspective. “When reviewing a chart, you start to recognize the individual behind the statistics. You see their journey—diagnosis, attempted treatments, and often, their last hope. Each data point represents a person with a story and the potential for hope,” she reflects.

Her message is profound: You don’t have to embrace the pharmaceutical industry to believe in science; what’s essential is understanding its foundations.

As persistent chronic health issues and intricate global health challenges grow, society’s reliance on ethical, inclusive, and high-quality research will be more pivotal than ever. Behind this pursuit, individuals like Jacobs play an indispensable role.

As Jacobs eloquently states, “We are not merely ensuring compliance; we are safeguarding the truth.”