David Staley
Strategic Regulatory & Operations Leader | Compliance, Quality & Risk Governance | National Thought Leader Advancing Integrity & Preparedness | Recognized for Intercultural Competence & Adaptability
- Role
- Director, Clinical Research Quality Assurance and Regulatory Support at Seattle Children's
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About David Staley
I’ve built my career over more than 20 years in human subjects research, regulatory…
Experience
Director, Clinical Research Quality Assurance and Regulatory Support
Jan 2023 — Present · Seattle, WA, US
Provide strategic leadership for clinical research quality assurance, regulatory compliance, and research operations across a top pediatric research institute. Founded the Office for Training, Regulatory Affairs, and Quality Support (TRAQS) to build a regulatory-ready culture and mitigate compliance risk. Designed and launched a Regulatory Preparedness Program to align SOPs, training, and workflows with FDA and ICH GCP requirements. Directed enterprise-wide implementation of a 21 CFR Part 11–compliant eRegulatory binder system and streamlined electronic consenting (eConsenting) processes to improve participant access. Serve as a trusted regulatory subject matter expert, collaborating with legal, compliance, and clinical leaders to resolve complex compliance challenges. Nationally recognized speaker and trainer on research compliance, ethics, and informed consent.
Education
Brigham Young University
Bachelor of Arts - BA, Spanish Translation
2003 — 2006
Portland State University
Master of Arts - MA, Spanish Language and Literature
2008 — 2010
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