Clinical Research Quality Assurance Specialist, Clinical Trials Unit

University Hospitals

. Coordinate activities within the Quality Assurance Program for the Clinical Research Unit .

Posted 10/2/2026full-timeCleveland • Ohio • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Clinical Research, ensuring compliance with regulatory guidelines and implementing process improvements. Proficient in managing clinical trials and training programs while maintaining high standards of documentation and communication.

Highest-signal resume keywords

Quality Assurance ReviewClinical Research ManagementRegulatory Compliance (FDA, ICH/GCP)Process Improvement ProjectsSoCRA Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceQuality ControlClinical ResearchRegulatory GuidelinesMedical TerminologyDocument Management SystemsDatabase ApplicationsExcel ProficiencyAccess ProficiencyWord Proficiency

Soft Skills

Organizational SkillsOral CommunicationWritten CommunicationInterpersonal SkillsProblem Solving

Certifications & Qualifications

SoCRA CertificationACRP Certified Professional (ACRP-CP)

Industry Keywords

Clinical TrialsGCP GuidelinesSOPsProtected Health Information (PHI)State and Federal Regulatory Guidelines

About the role

Key responsibilities & impact

Coordinate activities within the Quality Assurance Program for the Clinical Research Unit
Perform extensive quality assurance review of study documents and data across multiple complex studies in different therapeutic areas and phases
Report quality assurance findings to management and the research team
Assist the Quality Program Manager with departmental activities to maximize efficiency of management control systems, programs, policies, work methods and procedures
Establish and implement process improvement projects
Ensure clinical trials are initiated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and applicable regulatory regulations
Create and maintain an education and training program for the Clinical Trial Unit
Perform other duties as assigned
Comply with all policies and standards

Requirements

What you’ll need

Bachelor's Degree or 10 years of either clinical research experience or quality assurance experience or combination of both (Required)
5+ years of either quality assurance or quality control experience or clinical research experience or combination of both (Required)
3+ years of clinical research management experience, including sound knowledge of US regulatory requirements for clinical research including FDA, ICH/GCP (Required)
Outstanding organizational skills, oral and written communication skills and strong attention to detail
Strong interpersonal skills and ability to work as an effective team leader
Sound knowledge of state and federal regulatory guidelines
Ability to work independently on multiple tasks and manage time effectively
Medical terminology comprehension
Ability to self-monitor progress and complete assigned tasks independently
Good judgment, initiative and problem solving skills
Ability to follow through and consistently demonstrate primary job responsibilities are current
Excellent computer skills with working knowledge/proficiency in Excel, Access, Word, database applications, and ability to learn document management systems
Society of Clinical Research Associates (SoCRA) certification (Preferred)
ACRP Certified Professional (ACRP-CP) certification (Preferred)
Ability to safely and securely maintain Protected Health Information (PHI)
10% travel requirement

Benefits

Comp & perks

Annual training
UH Code of Conduct and UH policies and procedures addressing appropriate use of Protected Health Information (PHI) in the workplace
Full-time regular employee status