Very few physicians begin their careers with an eye on research. Moving into the role of Principal Investigator (PI) can be unexpectedly challenging, with demands that often take physicians by surprise.
“Much of my experience with clinical research centered around reviewing journal articles for clinical practice,” explains Daniel Williams, DO, FAAEM, who transitioned from emergency medicine into clinical research. “I felt familiar with the process and phases, but was unaware of the details that went into each study or the protocols that were written out for them.”
Taking on the PI role often means learning an entirely new discipline, with clinical care just one of many skills needed to be successful. Without structured support, the transition can be steep and many first-time PIs face a difficult learning curve, balancing unfamiliar systems and regulatory requirements with their clinical expertise.
This is a well-recognized challenge across the sector, and around two-thirds of PIs participate in a single study before stepping away from research, a pattern now openly referred to as the ‘one and done’ phenomenon. For sponsors and CROs who want PIs with experience, this creates a catch 22 – those with experience don’t always want to lead more trials, and those who want to lead trials may lack experience.
As one of the largest global patient networks, Velocity has sought to address this issue by developing its Principal Investigator Onboarding and Training (PIVOT) Program. The program offers a structured path into research for physicians new to the PI role, combining digital learning, practical immersion, mentorship, and leadership development. In doing so, it enables Velocity to provide sponsors with well-prepared, trial-ready investigators who can deliver consistently across its network.
Building confidence in PIs
Dr. Williams completed the PIVOT program when he first joined Velocity. Reflecting on the transition, he says structured preparation played a key role, “There is so much more to learn when you move from patient care into running trials. The language, the systems, the regulatory oversight; it’s a different world.”
The ability to shadow experienced PIs and learn directly from peers was particularly useful in helping him adjust.
“That hands-on exposure was critical,” says Dr. Williams. “Understanding simple things, like how other PIs set up their day to get all their tasks done and make sure that each study runs smoothly was eye opening, and meant I could hit the ground running. It was also helpful to see the role each PI plays as part of their team and how they support everyone.”
Mentorship and support
Mentorship is a big component of PIVOT, an aspect Dr. Williams is a huge advocate for. “Having Dr. Matthew Wenker to check in with, ask questions of, and learn from, makes a big difference. It’s easy to feel isolated when you’re new to research, PIVOT gives you that support structure and confidence to grow into the role.”
He emphasizes the value of a supportive team as well, “Having experienced coordinators and colleagues around me has been essential to my development as a PI. Sara, our site manager, and Alesia McFarlin, our sub-investigator, have not only brought deep research expertise but also offered hands-on support that helped me get comfortable with the systems and protocols early on. It makes all the difference to be part of a team that supports one another.”
Dr. Williams sees this support, together with the more formal structure provided by PIVOT, as a practical, accessible entry point into research.
“I always felt that the only way I could get into clinical research would be to enroll in a PhD program. However, there are opportunities to be involved either in place of clinical practice or a part of clinical practice. We are trained to problem solve and think critically, which gives us the skills to qualify us for a career in research.”
Always learning
Now fully established, Dr. Williams is one of two PIs at Velocity’s Anderson, SC site. He’s focused on actively expanding the site,
“We’re now running a broader portfolio and developing a diverse network of studies for people in our area to participate in. I have also been gaining credits to become board-certified in Obesity Medicine, which will give our site more opportunity and credibility for some of the upcoming studies on weight loss therapies.
“PIVOT has helped me feel comfortable in my role and confident that I can take on more responsibility while overseeing and supporting the team.”
Addressing industry challenges
Beyond individual development, programs like PIVOT play an important role in addressing broader industry challenges. Sponsors and CROs often hesitate to engage sites without experienced investigators. Yet, without structured pathways, new PIs struggle to gain that experience. And the administrative burden on PIs remains a leading cause of burnout and attrition. By helping close this gap, PIVOT enables Velocity to provide sponsors with a growing pool of well-supported, trial-ready PIs.
