ACRP Fellow Charts the Path of “Independents” in Clinical Research

Editor’s Note: As the Association of Clinical Research Professionals (ACRP) celebrates its 50th anniversary in 2026, we are pleased to continue our year-long series of Q&A interviews, “Forecasts from the ACRP Fellows: Insights on the Future of Clinical Research as ACRP Turns 50.” Our February guest is Jerry Stein, PhD, ACRP-CP, ACRP-MD, FACRP.

Q: For 50 years, ACRP’s mission to advance excellence in clinical research has empowered professionals like you to lead the industry forward. What’s a defining moment in your career when you felt proud to contribute to that legacy?

A: There have been several defining moments where ACRP has affected my career. In graduate school, I had excellent training conducting rigorous scientific experiments using animals. Like most ACRP members, I never planned a career in clinical research. When I moved to industrial clinical research, I received in-house training from my employer. For the first six years, I was never sure whether the training I received was consistent with international regulatory requirements or simply unique corporate procedures.

I was only able to gain a broader perspective when I joined ACRP, began reading the organization’s journals, and began attending local and national ACRP meetings. This knowledge allowed me to confidently speak up during internal meetings at my company; to talk about the ways we could improve our operations to become more efficient and ways we could improve compliance.

Q: Looking back on your experience in clinical research, what’s a lesson you’ve learned that points to how trials could be improved—whether in quality or efficiency? What changes would help make that improvement a reality, and how might ACRP play a role in supporting it?

A: For many years, a large proportion of new drugs and devices were developed using employees of big companies; everything was “in-house.” Today, this is a rare company model, and the use of contractors is the norm. Drilling further down, contractors can either be employees of contract research organizations/sponsors or independent workers hired to meet short-term needs. This is important since access to continued education is significantly impacted by your employment status, not just your job description.

As an “independent,” working on the sponsor’s side, I routinely receive training on protocol-specific requirements. In contrast, it is much more challenging and often expensive for independent contractors to keep up with changes in regulatory requirements and learn about best practices. I also need to worry about taxes and business expenses. I hope that ACRP continues to adjust its educational offerings and other services to meet the needs of the large number of members who are both independent clinical researchers and small business owners.

Q: As the clinical research enterprise faces unprecedented challenges like funding pressures, public engagement, and regulatory uncertainty, what’s your outlook on the current state and future prospects of the drug and device development industry?

A: Competition between sponsors, the limits to government spending on healthcare, and technological innovations will continue to significantly impact clinical research methodology. In the U.S., government and private spending on healthcare is relatively large compared to the rest of the world. The use of the internet, development of wearable medical devices, and the increase in work-at-home employment situations has significantly impacted drug and device development.

These changes have the potential to reduce costs and expand the opportunity for testing products using wider, more representative samples of study subjects. These trends have the potential for providing better pre- and post-market safety and efficacy information, eliminating harmful and ineffective products.

Q: Are there any other insights you’d like to share with our readers based on the trends you’ve been witnessing in the trenches in recent years?

A: I’ll focus on ACRP itself. ACRP is a wonderful organization. Networking has been the number one attribute that has motivated me to maintain my membership and stay active for close to 40 years. I have met so many exceptional people and benefited from their experiences and insights. I have also received a great formal education when attending the organization’s in-person meetings and online offerings.

Looking ahead, the organization’s challenge will be to continue to foster these networking opportunities while addressing the cost of running the organization during a period where product development and employment models, as well as regulatory requirements, are rapidly changing.

About Jerry Stein

Jerry is a long-time, active member of ACRP who joined the ACRP Fellows in 2021. He was one of the founding members of the ACRP North Texas Chapter and has led or participated in many national committees, made presentations at both local and national ACRP meetings, and served as an editorial advisor for the Association’s peer-reviewed Clinical Researcher journal. Based in the Dallas-Fort Worth area, he is currently an independent clinical research consultant and medical writer.

About the ACRP Fellows 

Being named a Fellow of the Association of Clinical Research Professionals (FACRP) is a mark of distinction. ACRP’s Fellowship program recognizes those who have made substantial contributions to the Association and the industry at large, as evidenced by: ACRP certification and continuing education, leadership contributions to ACRP, and contributions to the field of clinical research. 

Fellowship highlights excellence and commitment to ACRP, and is suitable for only a small, select number of clinical research professionals who are lauded as global leaders.

Edited by Gary Cramer