Clinical Research QA & Regulatory Compliance Leader

Apex Skin; Mayfield Heights (OH); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A growing health organization in Mayfield Heights, Ohio, is seeking an experienced Research Compliance (QA) Leader to oversee regulatory compliance across its Clinical Research Center Network. This role involves ensuring audit readiness, leading internal and external audits, and developing compliance policies. The ideal candidate will have strong leadership capabilities, regulatory expertise, and at least five years of experience in clinical research compliance, operating in a hybrid work environment.

Qualifications

• Minimum of five (5) years of experience in clinical research compliance or regulatory oversight.
• 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.

Responsibilities

• 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.
• Develop, implement, and maintain research policies, procedures, and guidance documents.

Skills

Strong leadership

Regulatory expertise

Attention to detail

Problem-solving

Clear communication skills

Collaboration

Proficiency in Microsoft Office

Education

Bachelor’s degree or higher in nursing, regulatory compliance, or research-related field

Job description

A growing health organization in Mayfield Heights, Ohio, is seeking an experienced Research Compliance (QA) Leader to oversee regulatory compliance across its Clinical Research Center Network. This role involves ensuring audit readiness, leading internal and external audits, and developing compliance policies. The ideal candidate will have strong leadership capabilities, regulatory expertise, and at least five years of experience in clinical research compliance, operating in a hybrid work environment.