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Miami Children's Health System
Miami, Florida, United States • On-site
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The Senior Research Compliance Specialist ensures adherence to regulatory requirements and institutional policies for clinical research studies. This role leads internal audits, manages FDA inspection preparations, and provides expert guidance to research teams to maintain compliance and quality standards.
Candidates must possess a Bachelor's degree in Sciences or Education and 7-10 years of clinical research, monitoring, or auditing experience. Additionally, 3-5 years of direct regulatory or compliance auditing experience is required, along with relevant professional certifications.
Job Summary
The Senior Research Compliance Specialist is responsible for ensuring adherence to applicable regulatory requirements, institutional policies, and quality standards governing clinical research activities, with a primary focus on industry-sponsored and other externally sponsored studies. This role independently leads internal auditing and preparatory audit activities and serves as the primary liaison for FDA audits and other external regulatory inspections, partnering with study teams to resolve compliance concerns identified during sponsor monitoring visits. The position provides advanced, subject-matter-expert-level compliance guidance, mentors junior compliance staff, and drives continuous quality improvement by identifying compliance risks, coordinating corrective and preventive actions, and partnering with the research education team to maintain audit readiness and regulatory compliance across the research portfolio.
Job Specific Duties
Minimum Job Requirements
Knowledge, Skills, and Abilities
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Offices: 3100 SW 62 Avenue, Miami, FL 33155, US
