Research Compliance (QA) Leader at Apex Clinical Research Center – Mayfield Heights, Ohio

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 documentation, data analysis, and use of electronic systems
• Visual acuity sufficient to review regulatory files, audit reports, study documentation, EMR systems, and compliance metrics
• Ability to speak, hear, and communicate clearly during meetings, training sessions, audits, and interactions with staff, sponsors, and regulatory agencies
• Ability to occasionally lift or move up to 15 pounds (files, binders, audit materials, or training resources)
• Work is performed in a professional office and clinical research environment with frequent collaboration across research, regulatory, and executive teams
• Hybrid work environment with required on-site presence for audits, inspections, staff training, and compliance oversight
• May require occasional travel between clinical research sites and attendance during regulatory inspections or audits
• Requires sustained attention to detail, analytical focus, and sound judgment when managing compliance findings and time-sensitive regulatory matters
• Must adhere to HIPAA, OSHA, GCP, ICH, and Apex Skin privacy, safety, and compliance standards

Apex Skin Culture

Apex Skin fosters a collaborative, patient-first environment built on compassion, clinical excellence, and teamwork. We believe in a respectful and supportive workplace where employees feel valued, trusted, and empowered to contribute to exceptional patient experiences and meaningful clinical care.

Employee Health & Safety Requirements:

All patient-facing employees are required to provide proof of a TB test within the past 12 months and an annual flu vaccination as part of Apex Skin’s employee health and safety protocols. The Hepatitis B vaccination series is also strongly recommended for clinical staff due to potential occupational exposure risks. Apex Skin complies with federal and Ohio law by providing reasonable accommodations for medical conditions or sincerely held religious beliefs that prevent vaccination. Employees seeking an accommodation should contact Human Resources for more information.

Equal Employment Opportunity Statement:

Apex Skin provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Apex complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.