Crystal Risotti

I have always been drawn to computers, but the direction of my career was largely shaped by the organizations where I worked. I entered the clinical trials field with no prior knowledge of the industry, starting in an entry‑level role and advancing steadily by studying, observing, and learning on the job. That growth eventually led to opportunities to participate in the DIA, where I completed additional coursework and deepened my expertise.

My career has consistently centered on the intersection of computer systems, software, and regulatory compliance in clinical trials with experience in GxP, ICH, FDA, EMA, and other regulatory authorities and regulations. Ten years into that journey—while raising my child as a single mother—I returned to college and earned my associate degree. My intention was to immediately continue into a bachelor’s program, but enrollment delays forced me to wait. During that time, my career continued to progress, and a decade later I returned to complete my bachelor’s degree. To me, that reflects tenacity: even with long pauses, I never abandoned my goals; I simply waited for the right moment.

Through my work opportunities, I gained additional valuable knowledge about Meaningful Use, the ACA, Medicare and Medicaid, and billing practices—insights that strengthened my ability to maintain balance between technical systems and regulatory requirements.

In one role, I was responsible for building a complete SDLC process with only one full‑time programmer and myself performing part‑time validation work. Despite extremely limited resources, I developed a compliant, streamlined framework that held up under more than 200 audits, many of them from major pharmaceutical companies. That experience taught me an important lesson: regulations dictate what must be done, but organizations have flexibility in how they meet those requirements. Over‑engineering is unnecessary; simplicity often leads to better adoption and more consistent execution.

My background as a trainer also helped me develop strong interpersonal and communication skills. I learned how to read people, adjust my approach, and explain complex concepts in ways that resonate with different audiences.

I would not be where I am today without the support of people who recognized strengths in me before I recognized them in myself. My faith has also played a meaningful role, reminding me that there is always a brighter path ahead as long as I stay focused.

The best career advice I’ve ever received is: don’t sacrifice better for best. This has guided me to focus on practical, meaningful progress rather than waiting for perfection or over-engineering, helping me make decisions efficiently, prioritize what truly matters, and deliver results without getting stalled by the pursuit of an unattainable ideal.

Observe those around you at work. Observe the corporate culture and opportunities. Ask questions and be curious. Find your interest and study - then network and find the right fit for you!

Additionally, give yourself grace. It takes time to learn all of the regulations for clinical trials, in addition to Information Technology regulations and best practices.

Always remember: success = ownership + execution + accountability

As AI becomes increasingly integrated into clinical trials, it is essential that we stay aligned with the rapidly evolving regulatory expectations and operational processes emerging across the industry. Our foremost responsibility remains unchanged: to protect patients and ensure that the products under evaluation are represented with accuracy, integrity, and transparency.

AI tools offer tremendous value in enhancing efficiency and insight, but their use must be supported by strong, well‑defined guardrails. Responsible adoption is not optional—it is foundational to maintaining trust, data quality, and regulatory compliance.

I have dedicated significant time to studying guidance from multiple regulatory authorities, and I am committed to applying that knowledge to support my client’s mission. My focus is on educating teams, strengthening organizational understanding, and developing procedures and policies that enable us to leverage AI effectively while keeping patient safety and study integrity at the forefront.

I value balance, integrity, and continuous growth in both my personal and professional life. Professionally, I am deeply committed to excellence, compliance, and collaboration, drawing on my extensive experience in IT quality assurance and pharmaceutical trials to support and guide teams while ensuring regulatory and operational standards are met. I take pride in mentoring others, improving processes, and integrating innovative solutions, including AI, to enhance efficiency and quality outcomes. Personally, I cherish experiences that bring peace, perspective, and connection, such as camping in my new camper, traveling to explore new cultures and regions, and volunteering through my church. These pursuits allow me to step away from daily routines, immerse myself in learning, and contribute meaningfully to my community, reflecting my belief in purposeful engagement, curiosity, and perseverance.