Ofelia Vargas-Shiraishi was flipping through channels on her TV one day when she saw a commercial for a new antimicrobial.
The name of the compound hit her: Children’s Hospital of Orange County (CHOC) had been one of the research sites for evaluating the medication before it became available on the market, and Ofelia had worked on the project as a clinical research coordinator (CRC).
“It made me realize how meaningful and impactful the career I chose is,” says Ofelia, manager of clinical research programs at CHOC.
A critical role
CRCs are critical to the CHOC Research Institute, which today has about 140 staff members, roughly 150 visiting professionals from neighboring research universities, and 700 or more investigators at any given time working on over 625 active human subject studies.
CRCs are a direct extension of principal investigators (PIs) on studies. They serve as ringleaders, managing projects from beginning to end with duties that entail regulatory support, submissions to CHOC’s two Institutional Review Boards, ensuring compliance with study protocols, and collecting data, among other duties.
It’s a rewarding career that, alas, poses challenges for Research Institute leaders. Many CRCs come to CHOC as interns or as students before going off to medical school or landing jobs with drug and medical device companies.
A new pilot program, said to be rare for a pediatric healthcare system, aims to attract and retain CRCs like Ofelia, who says her 31-year career has been extremely rewarding.
“The patient experience is what keeps me engaged,” Ofelia explains. “Clinical research is the best of both worlds. I can make a difference through science, and I can see the impact of my work on the patients and families we serve.”
Three interns in first cohort
The CHOC CRC Internship Program officially begins shortly with three interns who will take classes and rotate through different specialties and be mentored and exposed to all facets of clinical research.
If successful, the interns will be eligible to be considered for full-time CRC positions after earning a stipend their first year.
“Clinical research depends upon the efforts of highly qualified clinical research coordinators,” says CHOC Chief Scientific Officer Dr. Terence Sanger. “I’m very proud of the people we have and as we expand our clinical research enterprise here at CHOC, we recognize the need for more CRCs who are specialized in pediatrics and who understand our mission.”
Dr. Sanger says the internship program is designed to train pediatric CRCs for both CHOC’s needs and for the larger community of researchers in pediatrics.
“The innovative thing is that a pediatric hospital is doing this,” he says. “Most CRCs train in trade schools or universities or industry and come to hospitals.”
The need for the internship program became more apparent over the last few years, Dr. Sanger explains, particularly during COVID when there was a significant drop in the overall workforce, and it became harder to hire people as the number of research studies continued to rise.
“It’s about increasing the knowledge and the quality of pediatrics,” Dr. Sanger says, “and the more CRCs we have, the more research that is going to get done at CHOC.”
Growth and inspiration
Overseeing the CHOC CRC Internship Program are Oliver Vasquez, senior manager of clinical research, and Diana Zuniga, supervisor, clinical research coordinator.
“We’re a growing research enterprise,” says Oliver, who oversees 35 CRCs. “The intention of this program is to really grow our own CRCs and inspire them to choose this as their career here.”
Diana will run the pilot program, in which CHOC will pay for certification exams with the Society of Clinical Research Associates and the Association of Clinical Research Professionals as well as membership fees.
“The intention is that between Oliver and I, we can use our research expertise to show how rewarding and exciting a career in research can be,” Diana says.
A three-decade journey
Fresh from college with a degree in microbiology, Ofelia began working with Dr. Antonio Arrieta, who now is medical director of pediatric infectious diseases at CHOC, as he was completing his fellowship in infectious diseases at Miller Children’s Hospital in Long Beach and the UC Irvine.
After joining CHOC, Dr. Arrieta recruited Ofelia.
“I was very hesitant as I had primarily worked in a research laboratory, and I didn’t know the first thing about clinical research,” she recalls. “He continued to try to convince me for several months. Each time I said, ‘I don’t know the first thing about clinical research.’”
In October 1992, Ofelia decided to join CHOC. Mentors helped her get a handle on the job during her first few years here.
In 2010, she began to work in critical care research. The neonatology portfolio also began to grow, and now Ofelia manages both critical care and neonatology research. In 2017, she became involved in establishing a partnership with Rady Children’s Institute of Genomic Medicine.
“I’ve always had a lifelong love of learning,” Ofelia says, “and though it might sound a little cliché, even after almost 32 years at CHOC, I feel that I continue to learn every day.”
The heart of the mission
Oliver says he hopes to help the CHOC Research Institute enjoy a bigger profile on the national and global stage.
That is already happening. And CRCs are at the heart of all this research.
“This new internship program is in support of CHOC’s mission not only to advance and nurture the health and well-being of our patients, but also to find treatments and provide treatment that they have been unable to receive,” Oliver says.
“We pride ourselves on what impact we can have on our patients.”
Learn about pediatric research and clinical trials at CHOC
