In this episode of Clinical Trial Files, we sit down with Karen Cloete, founder of TASK Research Academy, to explore how clinical research training can, and must, evolve beyond silos and checklists.

With over 17 years of experience across clinical operations, monitoring, audits, compliance, and sponsor oversight, Karen shares her unconventional journey into clinical trials and how seeing the industry from every angle inspired her to rethink how professionals are trained. From CRA to site leader to sponsor-side expert, Karen explains why understanding the entire clinical trial lifecycle is essential for quality, compliance, and career growth.

The conversation dives into real-world challenges in global training, including language barriers, cultural context, and regulatory complexity, and how animation, simulation, and scenario-based learning can make training more inclusive, practical, and engaging. Karen also discusses TASK Research Academy’s innovative approach to experiential learning, internships, and workforce development, helping research-naïve professionals successfully enter the field.

We also unpack key updates from ICH E6 (R3), including service provider oversight, data governance, sponsor responsibilities, and decentralized trial considerations—what they mean in practice and where sites should focus now.

Whether you’re a CRA, coordinator, investigator, sponsor, or educator, this episode highlights why seeing the “big picture” in clinical research isn’t optional—it’s foundational.

In this compelling episode of Clinical Trial Files, hosts Karin Avila and Taymeyah Al‑Toubah sit down with Dr. Hillary Edwards from the University of Maryland’s Patients Program. They explore the evolution of patient‑centered and ethical clinical research—from historical wrongs like the Nuremberg Trials and Tuskegee to modern movements such as the formation of PCORI and the impact of COVID‑19 in increasing public trust and trial accessibility.

Dr. Edwards shares how the Patients Professors Academy fosters shared governance, continuous patient engagement, and a common research language to better enroll, retain, and serve participants. Through vivid metaphors (like comparing radiation therapy to spray versus stream) and personal anecdotes—from dentist relationships to international travel— illustrates how empathy, clarity, and inclusivity transform clinical trials into trustworthy, equitable, and human-centered endeavors.

In this inspiring episode of Clinical Trial Files, Dr. Jaydira Del Rivero, triple-board-certified oncologist and endocrinologist at the NIH, shares her deeply personal journey from internal medicine to leading global research on rare endocrine cancers. Joined by hosts Taymeyah Al-Toubah, Karin Avila, and Roberto Torres, Dr. Del Rivero reflects on overcoming early career setbacks, the value of mentorship, and the importance of lifelong learning. She breaks down complex concepts like natural history studies, explains the challenges of designing trials for ultra-rare tumors like pheochromocytomas and ACC, and makes a compelling case for personalized medicine, improved community education, and quality-of-life endpoints in research. Her compassion, humility, and patient-driven mission offer rare insights into the human side of science.