Alums Become the ‘Eyes and Ears’ of Clinical Research

Meet the trio of MCPHS Community members putting ethics and patient care first while coordinating research efforts at Mass Eye and Ear.

A clinical trial is one of the most regulated and complex functions of the healthcare system, and for good reason. Most drug therapies, medical devices, and procedures go through at least one trial before reaching patients. The process, from start to end, takes years.

While so much focus is placed on the result, Dr. Stacey Ellender has built a career on the process of a clinical trial—from ideation to protocol development, data collection planning, testing, and compliance—and is inspiring Massachusetts College of Pharmacy and Health Sciences (MCPHS) students to do the same.

“I tell clinical research coordinators that they are the eyes and ears of the [research] institution,” she said. “It’s their job to pay attention. They make research more detailed, the findings more reliable, and the status of the institution grow.”

As a leader in the research department of Mass Eye and Ear, a member of Mass General Brigham, Dr. Ellender mentors a growing contingent of MCPHS alums working as coordinators, driving the organization’s clinical research projects forward. Mwangi Kagai, MS ’23, BS ’22, and Fabian Perez, MS ’24, BS ’22, had parallel journeys at MCPHS, going from undergraduate pharmacy programs to graduate pharmaceutical business programs. Today, they’re using what they learned to ensure clinical trials are conducted accurately and ethically.

Leading with a Morality

When Kagai is in the clinic, observing patient tests and treatments as part of a clinical research project, he is on high alert.

“More than anything, research is about patient care,” he said. “I want to make sure patients know that this is a safe environment and that their providers want to see them do better.”

Kagai takes his role as a Clinical Research Coordinator seriously, putting the patient’s best interest first. “It’s a big responsibility,” he said. “We may not have doctorates, but our voices and opinions in research settings matter.”

Kagai is from a family of healthcare workers. After they immigrated to the U.S. from Kenya, his mom became a nurse, and his dad became a respiratory therapist, so healthcare was a logical path. He earned a bachelor’s in pharmaceutical sciences but was still searching for a discipline that felt right. Ultimately, he enrolled in the Master of Science in Regulatory Affairs and Health Policy.

“I love research for the possibility, for the chance to create something out of nothing,” Kagai said. “Clinical research and regulatory affairs are two sides of the same coin, and in my work, they coexist.”

Kagai spends most of his days attending or preparing for clinic visits, reviewing the protocol, and preparing and collecting the required paperwork. He’s also obligated to report any issues that arise.

“Dr. Ellender has shown me that clinical research isn’t about curing people or making money; it’s about whether a project is ethical,” he said. “It’s nice that within our group, the people who came from MCPHS have the same thought process, common sense, and sense of moral justice about our work.”

‘Coordinating the Coordinators’

After taking a few pharmacy courses at his high school in California, Perez moved to the East Coast to attend MCPHS. He was the first person in his family to move away and the first to attend college. “My first year was really tough, but I just had to trust myself and the choices I made,” he remembered. “I had made it so far, and I wasn’t going to stop until I crossed the finish line.”

Along the way, he took a class in Food and Drug Administration (FDA) regulation and wanted to know more. So, he set a new goal and enrolled in the Master of Science in Clinical Research. “I went straight into my master’s with no work experience. If I had the opportunity to go back to school now, I would enjoy it more.”

Perez is a Senior Clinical Research Coordinator, working specifically in inherited retinal disorders. He’s learning how to manage projects, “coordinating the coordinators,” as he described, and ensuring the entire team is following the research protocols. He’s also working with patients, making sure they have what they need to get to the clinic and participate.

“I use what I learned in protocol development with Dr. Ellender every day,” he said. “Everything I learned in that course and in the program is slowly applying to what I do every day as I advance my career.”

While Perez has worked on many clinical projects, he wants to move to the startup phase, working on a research project to secure the site, enroll patients, and see the project through launch.

“I enjoy clinical research because it brings hope to people who need it most,” he said. “It’s a long, tough process, but it’s an honor to do this work.”

Growing the Team

At Mass Eye and Ear, Perez and Kagai sit a few feet apart. Their paths, from undergrad to graduate school and into the professional world, have been parallel. Now, they’re both planning on building long-term careers in the clinical research space. And Dr. Ellender has been there for it all.

As she teaches protocol development, Dr. Ellender makes notes of MCPHS students who want to excel, keeping them in mind for coordinator opportunities. Likewise, she encourages coordinators to consider a graduate degree from MCPHS.

“We bring people in from [MCPHS] because they elevate all of our work,” she explained. “They ask better questions and understand the protocol in more detail. They make everybody better.”