Clinical Research Quality Assurance Specialist, Seidman Cancer Center (Hybrid)

Clinical Research Quality Assurance Specialist, Seidman Cancer Center (Hybrid)

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 of different therapeutic areas and phases and report findings to management and research team. Assist the Quality Program Manager in regard to specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Establish and implement process improvement projects. Ensures that clinical trials are initiated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. Create and maintain an education and training program for the Clinical Trial Unit.

Education: Bachelor's Degree or 10 years of either clinical research experience or quality assurance experience or combination of both (Required). Master's Degree (Preferred).

Work Experience: 5+ years of either quality assurance or quality control experience or clinical research experience or combination of both; (Required) and 3+ years of clinical research management experience including sound knowledge of US regulatory requirements for clinical research including FDA, ICH/GCP (Required).

Knowledge, Skills, & Abilities: 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. Detail-oriented person with the 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 a variety of software environments (ie Excel, Access, Word, database applications) and ability to learn document management systems.

Physical Demands: Standing Occasionally, Walking Occasionally, Sitting Constantly, Lifting Rarely 20 lbs, Carrying Rarely 20 lbs, Pushing Rarely 20 lbs, Pulling Rarely 20 lbs, Climbing Rarely 20 lbs, Balancing Rarely, Stooping Rarely, Kneeling Rarely, Crouching Rarely, Crawling Rarely, Reaching Rarely, Handling Occasionally, Grasping Occasionally, Feeling Rarely, Talking Constantly, Hearing Constantly, Repetitive Motions Frequently, Eye/Hand/Foot Coordination Frequently.

Travel Requirements: 10%

Primary Location: United States-Ohio-Cleveland

Work Locations: 11100 Euclid Avenue Cleveland 44106

Job: Research

Organization: Clinical_Research_Center_UHC

Schedule: Full-time

Employee Status: Regular

Shift: Days

Job Type: Standard

Job Level: Professional

Travel: No

Remote Work: Hybrid

Job Posting: Jul 10, 2026, 3:06:47 PM