Kali Wyatt
Chicago
Summary
Aspiring healthcare attorney with 7+ years of experience in regulatory compliance, risk management, health policy implementation, and audit oversight across clinical research and healthcare operations. Experienced in interpreting federal regulations (FDA, ICH-GCP), drafting SOPs and regulatory documentation, managing IRB submissions, and strengthening ethical and legal adherence. MHA graduate committed to advancing health equity and healthcare reform through law and policy.
Overview
8
8
years of professional experience
3
3
Certifications
Work History
Regulatory & Quality Assurance Specialist
Flourish Research
Chicago
01.2024 - Current
- Maintain compliance across 67 active clinical trials by ensuring alignment with FDA, ICH-GCP, IRB, and internal SOP requirements.
- Prepare and submit key regulatory documents including IRB applications, ICFs, 1572s, safety reports, and protocol amendments.
- Lead site-wide audit readiness initiatives; develop CAPAs, quality metrics, and process improvements to reduce regulatory risk.
- Draft SOPs, regulatory memos, deviation reports, and compliance documentation to support legal/ethical adherence in human subjects research.
- Train and mentor regulatory and clinical staff on compliance expectations, documentation standards, and policy interpretation.
- Build tracking systems to monitor deviations, training gaps, document accuracy, and inspection preparedness.
Senior Clinical Research Coordinator + Quality Oversight Lead
M1 Health
Orland Park
01.2023 - 01.2024
- Directed study start-up activities requiring regulatory interpretation and IRB protocol review.
- Ensured adherence to GCP, HIPAA, IRB standards, and sponsor policies; served as compliance liaison.
- Authored compliance documents including monitoring reports, risk assessments, and regulatory correspondence.
- Completed multiple sponsor audits with zero major findings.
Interim Office Manager
Dovilan Wyatt MD LLC
Chicago
01.2018 - 01.2022
- Led daily operations of private ophthalmology practice including compliance oversight and workflow optimization.
- Ensured HIPAA adherence, staff onboarding, and policy alignment.
- Strengthened operational governance and reduced administrative errors.
Lead Clinical Research Coordinator
Dovilan Wyatt MD LLC
Chicago
01.2018 - 01.2022
- Oversaw clinical research regulatory documentation for federally regulated ophthalmology studies.
- Managed FDA audit with no 483 observations, demonstrating strong compliance readiness.
- Served as primary compliance contact for investigators and sponsors.
Education
Master of Healthcare Administration -
Northwestern University
Evanston, IL08.2024
Bachelor of Arts - Public Health
Brown University
Providence, RI05.2017
Skills
- Regulatory Interpretation (FDA, ICH-GCP, IRB)
- Health Policy Analysis
- Audit & Inspection Readiness
- SOP & Policy Drafting
- Risk Assessment & Mitigation
- Ethical Decision-Making
- Quality Management Systems
- Legal/Regulatory Writing
- Documentation Standards
- Stakeholder Communication
Community Service
- Delta Sigma Theta Sorority, Inc., Financial Secretary & Community Organizer
- Prevent Blindness America, Volunteer vision screener & community outreach assistant
- Brown University, Mentor (Black Student Union), Women in Business member, and organizer for major philanthropic initiatives
Certification
ICH Good Clinical Practice E6 (R3)
Timeline
Regulatory & Quality Assurance Specialist
Flourish Research
01.2024 - Current
Senior Clinical Research Coordinator + Quality Oversight Lead
M1 Health
01.2023 - 01.2024
Interim Office Manager
Dovilan Wyatt MD LLC
01.2018 - 01.2022
Lead Clinical Research Coordinator
Dovilan Wyatt MD LLC
01.2018 - 01.2022
Master of Healthcare Administration -
Northwestern University
Bachelor of Arts - Public Health
Brown University