Clinical Trials QA Specialist – Hybrid, Quality & Compliance

University Hospitals; Cleveland (OH); Hybrid; USD 85,000 - 110,000; Full time

Job summary

University Hospitals seeks a Clinical Research Quality Assurance Specialist within the Clinical Trials Unit. This hybrid role focuses on coordinating QA activities, reviewing study documents, and supporting process improvements to maximize trial compliance and efficiency.

The position requires strong regulatory knowledge, 5+ years in QA/clinical research, and 3+ years in clinical trial management, with preference for advanced degrees.

Qualifications

• Requires Bachelor’s Degree or 10 years in clinical research or QA, or both.
• 5+ years QA or clinical research experience (Required).
• 3+ years clinical research management experience including FDA/ICH/GCP knowledge (Required).

Responsibilities

• Coordinate activities within the Quality Assurance Program for the Clinical Research Unit.
• Perform extensive QA review of study documents and data across multiple complex studies.
• Assist the Quality Program Manager with departmental activities and process improvement projects.
• Ensure trials are initiated, documented and reported in compliance with SOPs, GCP, sponsor guidelines and regs.
• Create and maintain an education and training program for the Clinical Trial Unit.

Skills

Organizational skills

Communication

Team leadership

Regulatory knowledge

Detail oriented

Problem solving

Education

Bachelor's Degree

Master's Degree (Preferred)

Tools

Excel

Access

Word

Database apps

Job description

University Hospitals seeks a Clinical Research Quality Assurance Specialist within the Clinical Trials Unit. This hybrid role focuses on coordinating QA activities, reviewing study documents, and supporting process improvements to maximize trial compliance and efficiency.

The position requires strong regulatory knowledge, 5+ years in QA/clinical research, and 3+ years in clinical trial management, with preference for advanced degrees.