Ana Orlowsky

Background

About Ana Orlowsky

Seasoned Clinical Research Associate (CRA) with specialized graduate training in biopharmaceutical clinical research—bringing a well-rounded background in clinical operations, site management, regulatory compliance, and study start-up feasibility. I have supported the oversight of Phase I–IV clinical trials across oncology, hematology, cardiovascular, and metabolic indications in compliance with the U.S. FDA and ICH-GCP standards. With a MPA foundation in public health systems, regulatory policy, and a candidate for a MSCR—I hold a strong commitment to scientific rigor in clinical operations and strategic trial management. My prior experience as a federal compliance auditor has also developed my regulatory insights to every aspect of clinical operations, from site management to stakeholder engagement. Beyond my day-to-day clinical operations, I am actively engaged in graduate-level scholarly research through the Master of Science in Clinical Research program at UNC-Wilmington. My goal is to advance a patient-centered approach while maintaining scientific validity and respect for the available evidence.