Kelly Willenberg & Associates

Cynthia Dunn


Cynthia (Cindy) Dunn is an experienced and diverse clinical research professional with over 25 years of healthcare experience including: Clinical Research, Clinical Research Compliance, and Oncology Nursing. Having worked as an Oncology Research Coordinator, Interim Director Clinical and Regulatory Operations, Monitor, Project Manager and CRA Manager, Cindy offers valuable insight from both the site and sponsor perspectives of clinical research.

Cindy has consulted with multiple research sites in the following areas: Operations enhancement and Process Improvement, Audits (of Phase I-IV trails, including investigator initiated studies (Good Clinical Practice (GCP)))), Inspection Readiness, Gap Analysis; Risk Assessment, Clinical Research Training (e.g. Clinical Research; Investigation New Drug (IND) studies; GCP etc.) Interim Staffing; Due Diligence Assessment and Standard Operating Procedure (SOP) infrastructure (including tools/checklist development & implementation). Additionally, she has provided a variety of services to multiple pharmaceutical companies including: Monitoring (including Risk Based Monitoring), Site Management; Clinical Research Associate (CRA) Management, Contract Research Organization (CRO) Oversight, Vendor Management, Project Management, Auditing, Trial Master File (TMF) Management, Training, and Inspection Readiness.

Cindy holds a Master of Science in Nursing in Clinical Research Management from Duke University. She also holds research related certifications from ACRP and SOCRA and has lectured locally, nationally and internationally on various topics related to clinical research.