Research Compliance (QA) Leader

Position Overview

Apex Skin and the Apex Clinical Research Center are physician-led, rapidly growing organizations committed to delivering exceptional patient experiences while advancing high-quality clinical research. We are seeking an experienced Research Compliance (QA) Leader to oversee regulatory compliance across our Clinical Research Center Network.

This role supports research operations by ensuring audit readiness, leading internal and external audits (including FDA inspections), developing and maintaining institutional policies, and providing oversight of research compliance, regulatory, and data management functions. The ideal candidate demonstrates strong leadership, regulatory expertise, attention to detail, and a commitment to fostering a culture of quality, ethics, and continuous improvement across all research sites.

Schedule

• Full-time, salaried, exempt position
• Hybrid work schedule
• On-site presence required three (3) days per week
• Remaining work performed remotely, including frequent collaboration with sponsors
• Monday–Friday business hours, with flexibility based on operational needs

Essential Functions

• Ensure compliance with FDA, OHRP, GCP, ICH, CMS, IRB, and applicable state and federal regulations
• Serve as primary contact for FDA and other external audits; lead audit preparation, execution, and follow-up
• Plan, conduct, and oversee internal compliance audits across all sites
• Develop, implement, and maintain research policies, procedures, and guidance documents
• Maintain continuous audit readiness across facilities and departments
• Provide oversight of Regulatory and Data Management teams, including supervisory responsibilities as needed
• Act as subject matter expert for clinical, regulatory, and research billing compliance
• Monitor performance metrics, identify trends, and drive corrective and preventive actions
• Communicate compliance findings, action plans, and outcomes to executive and research leadership
• Develop and maintain a comprehensive staff training and onboarding program
• Ensure completion and documentation of required training and orientation
• Lead ongoing education on regulatory requirements and industry best practices
• Support protocol review, staff education, and resolution of audit or monitoring findings
• Perform routine audits of regulatory files, source documents, CRFs, drug accountability, and financial records
• Establish systematic processes to ensure sustained compliance and inspection readiness
• Support continuous improvement initiatives related to research quality and compliance

Qualifications

• Bachelor’s degree or higher in nursing, regulatory compliance, or a research-related field
• Minimum of five (5) years of experience in clinical research compliance or regulatory oversight
• Demonstrated leadership with strong accountability and clear communication skills
• Collaborative, team-oriented approach with the ability to work effectively across departments
• High attention to detail with strong problem-solving and sound decision-making abilities
• Proficiency in Microsoft Office (Excel, Word, PowerPoint), Microsoft Teams, and large database systems

Physical Requirements & Work Environment

• Prolonged periods of sitting, standing, and walking in office, clinical research, and audit settings
• Frequent use of hands and fingers for typing, reviewing documenta