How to Become a Principal Investigator for Clinical Trials

principal investigator clinical trials

According to a recent study, Black professionals make up less than 4 percent of NIH-funded principal investigators and only 1.8 percent of all active clinical investigators. While clinical trials play a critical role in advancing medicine, Black Americans remain underrepresented not only as participants but also in the leadership roles that help shape research. 

Part of this disparity may stem from a lack of awareness and exposure to clinical research careers. Yet, one of the most influential positions in the field is the principal investigator (PI) — the physician responsible for leading clinical trials and ensuring studies meet regulatory, ethical, and safety standards. 

As conversations around health equity continue to grow, experts say increasing diversity among principal investigators is just as important as increasing diversity among clinical trial participants. “The challenge is not a shortage of Black talent in clinical research; it is ensuring that talent is seen, developed, and given the opportunity to lead,” says Joyce N. Nortey, MPH, MSBH, Sr. Director, Clinical Research & Operations at Evidation Health and Research Advisor for the Fibroid Foundation.

For those interested in combining medicine, research, and leadership, becoming a Principal Investigator can be a rewarding career path. 

Here’s what aspiring researchers should know about the role and how to get started. 

What Does The Principal Investigator Role Entail?

A PI serves as the physician responsible for leading clinical trials, protecting participant safety, and ensuring studies meet ethical and regulatory requirements. The role requires balancing patient care, research oversight, and collaboration with research teams. 

For Greg Marchand, MD, a board-certified OB-GYN and surgeon, serving as a principal investigator is integrated into his clinical practice. “As a board-certified OB-GYN and full-time practicing surgeon, my days are packed with seeing patients in clinic, performing surgeries, and making sure every woman I treat feels heard and cared for,” Dr. Marchand says. 

In addition to treating patients, Dr. Marchand reviews participant eligibility, oversees safety monitoring, works with research coordinators, and ensures study protocols are followed. He says the principal investigator is ultimately responsible for the medical integrity of a trial. 

“My leadership means I am ultimately responsible for the medical integrity of the trial,” he says. “That includes making sure protocols are followed, protecting participant safety, and stepping in whenever a clinical judgment call is needed.” 

According to Dr. Marchand, one of the most rewarding aspects of the role is seeing research evolve into treatments that can improve patients’ quality of life. 

How To Become a Principal Investigator 

There is no single path to becoming a principal investigator, but most begin with a strong educational and clinical foundation. According to the Association of Clinical Research Professionals, principal investigators typically hold advanced healthcare degrees such as MD, DO, PharmD, or PhD and gain experience working on clinical trials before leading studies themselves.

Dr. Marchand says his journey began after residency and fellowship training, where he focused on building clinical expertise while remaining active in research. “I focused on publishing research regularly, presenting at national meetings, and developing expertise in areas like advanced laparoscopy and single-port techniques,” he says.

Over time, his research experience and clinical expertise led to opportunities to serve as a principal investigator on multiple FDA clinical trials. For physicians and medical students interested in pursuing a similar path, Dr. Marchand recommends starting with smaller research opportunities and gradually building experience. “Start small by joining as a sub-investigator on trials at your hospital,” he recommends. “Most importantly, keep that fire for helping patients through better treatments because that passion will carry you through the long process.” 

Beyond medical expertise, Dr. Marchand says successful principal investigators need strong communication skills, attention to detail, ethical judgment, empathy, and the ability to work collaboratively with research teams. 

principal investigator
Photo by Cottonbro

Career Pathways Into Clinical Research 

One common misconception is that clinical research is only for physicians and scientists. In reality, the field offers opportunities for professionals from a wide range of backgrounds. 

“Clinical research is how we determine what works, for whom, and under what circumstances in healthcare,” Nortey says. “It is the process that transforms scientific discoveries into medicines, medical devices, digital health technologies, and care approaches that improve and save lives.” 

Nortey notes that while medicine, nursing, pharmacy, public health, and biomedical sciences remain common pathways into clinical research, the industry increasingly needs professionals with expertise in engineering, data science, artificial intelligence, digital health, behavioral science, and patient engagement. 

For students and early-career professionals interested in entering the field, she recommends gaining foundational knowledge through training in Good Clinical Practice (GCP) and Human Subjects Research (HSR), as well as pursuing internships, fellowships, and workforce development programs. 

“My advice is to think beyond a specific job title and focus on the impact you want to have,” Nortey says. “Clinical research is one of the few fields where you can influence healthcare at scale.” 

Why Representation Matters in Clinical Trials 

Diversity among principal investigators is about more than representation — it can strengthen the quality, relevance, and impact of clinical research.

PIs influence study design, determine which populations are included in research, and help shape how findings are interpreted and applied. According to Nortey, diverse leadership teams bring broader perspectives that can improve decision-making and innovation.

“Diverse PIs bring different educational backgrounds, professional experiences, cultural perspectives, and lived experiences to the research process,” she says. “When leadership teams include people who think differently and approach problems from multiple angles, they are more likely to identify blind spots, challenge assumptions, and develop innovative solutions.” 

Nortey also notes that diverse investigators can help bridge longstanding trust gaps between researchers and historically underrepresented communities by bringing cultural understanding and authentic community engagement strategies to their work. 

Beyond improving research today, representation in leadership can inspire future generations of researchers. “When patients, students, and early-career professionals see diverse leaders conducting groundbreaking research, it expands aspirations and helps build the next generation of investigators,” Nortey says.

As healthcare continues to evolve, experts say ensuring diversity among those leading research will be critical to creating treatments, technologies, and innovations that serve all communities.

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BlackDoctor Pro is an online destination created specifically for Black doctors and other culturally-sensitive healthcare professionals. Our platform delivers trusted, relevant, and timely medical content, including in-depth articles, the latest treatment updates, healthcare policy, and emerging clinical studies.
AI-Powered Search. Human-Created Content.