Kelly Willenberg & Associates

Wendy Schroeder


Wendy  is a registered nurse by profession. In addition to 14 years of bedside nursing with cardiology and oncology expertise, she has over 20 years of clinical trials experience in varying roles including research operations, regulatory oversight and clinical trial billing. Wendy has filled key research leadership roles in clinics, nonprofit hospitals, for profit diagnostic laboratories, tablet technologies, and small biotech industry/sponsor companies. Wendy has reviewed over 100 clinical trial protocols to make coverage determinations and negotiate budgets; and she has developed policy and process flow to manage research billing compliance. Her most recent experience is in the personalized medicine space and includes a deep knowledge of regulatory oversight, clinical study requirements and billing/coding considerations for in vitro diagnostic (IVD) medical devices and laboratory-developed tests (FDA/CLIA). She has shared her domain knowledge and expertise as an expert speaker at professional conferences (ACRP, SoCRA, SRA, MAGI, eXL Pharma) and in multiple professional and peer-reviewed journals.

Wendy earned her Bachelor of Science in Nursing degree from Arizona State University and she is certified as a clinical research coordinator (CCRC/ACRP) and a research contracts professional (CRCP/MAGI).

Wendy enjoys grandchildren, travel and Harley Davidson “wind therapy” in her spare time.