This post is part of Health Wallet's ongoing series, "Meet a Researcher," which is an opportunity to get to know the people hard at work to bring us the future of medicine. Each of these profiles spotlights a clinical researcher who we admire and whose work is critical to advancing medical discovery. 

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What is your job and how would you describe it?

My name is Ayesha Fraser and my friends call me Aya. I work on blood and marrow transplantation and cellular therapy trials by leading the trials’ regulatory affairs and quality management. This means I help researchers comply with research regulations, which can be complex to understand and a lot of work to manage. From HIPAA to Good Clinical Practices, regulations exist to make sure research is done ethically, safely, and to the highest standard of scientific rigor. 

What inspired you to enter the field of clinical research?

Some of us find our calling and for others, their calling finds them. I am the latter. After working in laboratory research, I took the leap of being a newcomer to clinical research and regulatory affairs. Even though it was challenging, I realized that my skills helped me get up to speed quickly. I’ve found a fundamental understanding of medical and biological sciences is helpful, especially the principles of rigor and reproducibility.

Now seven years later, I am still in regulatory affairs, and eager to continue learning and contributing to the evolving research industry.

What is one of the most interesting or rewarding projects you've worked on in clinical research?

In my job, I help scientists who are leading clinical trials receive FDA approval to begin their research -- this is the first step of launching a clinical trial. One of my most rewarding projects was working with Dr. Casey Halpern of Penn Medicine to launch a study evaluating whether neuromodulation (the targeted use of a technology that affects nerve activity) could help patients struggling with obesity. These patients had already unsuccessfully tried medication and gastric bypass surgery, so this trial represented a new potential treatment option.

I was inspired by seeing the clinical trial go from paper to reality when I provided regulatory oversight for the trial's first surgery. There, I witnessed the research team’s exceptional work and dedication. And I saw just how many people work to make sure patients are safe and cared for, from doctors to administrative staff to regulatory affairs professionals like me. Everyone in clinical research has a role and we could not be successful in improving patients’ lives without each other.

What is one of the greatest challenges you face in clinical research?

Sometimes people underestimate the amount of effort, time, dedication, and discipline required to conduct clinical research. Because this work can be so difficult and complex, one of my roles is to train clinical researchers on the evolving research landscape so they can make regulatory compliance not just part of their trials but part of the organizational culture itself. Regulatory affairs is not just about paperwork and rules--it’s about having a culture that prioritizes understanding and following the applicable regulations. The culture of an organization is its life force; each team member’s actions contribute to building and maintaining culture.

When you're having a challenging day, what story or experience keeps you motivated?

I'm motivated by working with exceptional doctors who care for their patients and dedicate their careers to researching treatments that can improve people’s lives. Getting new treatments to patients is the product of a huge team effort. I take satisfaction in knowing that my job managing the regulatory side of things gives doctors options for new treatments while ensuring the safety of patients. This inspires me to keep going and continually improve my contributions to advancing clinical research.