Kristi Sanford Email and Phone Number

I am currently responsible for developing and maintaining leading edge practices for our operations function, focused on effective solutions and continual improvement. As a leader, I create empowered teams who are engaged champions of their areas of expertise.I consider myself an operations, compliance and quality professional, having hands-on experience with corporate integrity agreements, healthcare law compliance, marketing and promotional compliance, and development of compliance program elements.I have served as an internal expert for state/federal marketing and disclosure law components including transparency reporting (Sunshine/Open Payments), disclosures and compliance certifications. I have also been able to build compliance monitoring and auditing programs based on risk assessments, business profiles and mandated requirements (CIA).In the past, I both led and supported quality systems building expertise in internal processes and systems, databases, clinical study reports, critical documentation, investigator sites, and vendors/subcontractors. I am a skilled facilitator of pharmaceutical, biotechnology and regulatory audits of varying scope and size including FDA, DEA, CLIA, and Independent Review Organizations (IRO).Specialties: Medical Operations, Educational Grants, Investigator Initiated Studies, Clinical Study Management, Healthcare law (e.g., Stark, AKS, FCA), Compliance Program Development and Monitoring, CIA Implementation, GxP auditing, CLIA/CAP experience, CAPA Program Development and Maintenance, Risk Mitigation, Internal Investigations, Regulatory Inspections, Technical Writing, Training