University of Utah
Associate Director, Clinical Research Quality Assurance Management
University of Utah, Salt Lake City, Utah, United States, 84193
Overview
Job Summary
The Associate Director of Clinical Research Quality Assurance is responsible for the preparation, implementation and coordination of local, national and international research projects and research collaborations at UREAD. They will closely collaborate with the UREAD Director, Professor Fleckenstein, the Senior Research Manager, the Team Leader of readers and all other staff to ensure that goals and expectations are met for the conduct of retinal research projects and reading center services in clinical studies. Learn more about the benefits of working for University of Utah: benefits.utah.edu
Responsibilities Quality assurance and quality control of reading center operations; ensure compliance with protocols, regulatory regulations, and overall objectives; ensure that targets, timelines, budgets, and requirements are met.
Management of the internal Quality Management System; revise and expand internal SOPs (Standard Operational Procedures).
Overview and perform study startup, budgeting and invoicing.
Interact with sponsors regarding organization of reading center services.
Build, review, and maintain clinical databases, data collection tools, and applications, particularly based on REDCap databases.
Serve as liaison with study sponsor and CRO as directed.
Create, review, and maintain study documentation, such as Case Report Forms (CRFs) and Data Transfer Agreements (DTAs).
Compile, analyze, clean, and validate clinical trial data; overview data transfers to the study sponsor.
Identify and resolve discrepancies and issues with clinical data.
Develop data management reports and monitor study status to ensure timelines are met.
Conduct highly complex work, unsupervised and with extensive latitude for independent judgment.
Assist UREAD staff members as necessary to meet the needs of the various studies.
Minimum Qualifications EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor\'s degree = 4 years of directly related work experience).
Associate Director, Clinical Research Quality Assurance: Requires a bachelor\'s (or equivalency) + 10 years or a master\'s (or equivalency) + 8 years of directly related work experience in clinical research and quality assurance.
Preferences Background in quality management and clinical research.
Details Requisition Number: PRN43973B
Full Time or Part Time: Full Time
Work Schedule Summary: Hybrid remote/in-office
Department: 00870 - Ophthalmology-Research
Location: Campus
Pay Rate Range: $85,000 - $105,000
Close Date: 4/7/2026
Open Until Filled: Yes
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Job Summary
The Associate Director of Clinical Research Quality Assurance is responsible for the preparation, implementation and coordination of local, national and international research projects and research collaborations at UREAD. They will closely collaborate with the UREAD Director, Professor Fleckenstein, the Senior Research Manager, the Team Leader of readers and all other staff to ensure that goals and expectations are met for the conduct of retinal research projects and reading center services in clinical studies. Learn more about the benefits of working for University of Utah: benefits.utah.edu
Responsibilities Quality assurance and quality control of reading center operations; ensure compliance with protocols, regulatory regulations, and overall objectives; ensure that targets, timelines, budgets, and requirements are met.
Management of the internal Quality Management System; revise and expand internal SOPs (Standard Operational Procedures).
Overview and perform study startup, budgeting and invoicing.
Interact with sponsors regarding organization of reading center services.
Build, review, and maintain clinical databases, data collection tools, and applications, particularly based on REDCap databases.
Serve as liaison with study sponsor and CRO as directed.
Create, review, and maintain study documentation, such as Case Report Forms (CRFs) and Data Transfer Agreements (DTAs).
Compile, analyze, clean, and validate clinical trial data; overview data transfers to the study sponsor.
Identify and resolve discrepancies and issues with clinical data.
Develop data management reports and monitor study status to ensure timelines are met.
Conduct highly complex work, unsupervised and with extensive latitude for independent judgment.
Assist UREAD staff members as necessary to meet the needs of the various studies.
Minimum Qualifications EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor\'s degree = 4 years of directly related work experience).
Associate Director, Clinical Research Quality Assurance: Requires a bachelor\'s (or equivalency) + 10 years or a master\'s (or equivalency) + 8 years of directly related work experience in clinical research and quality assurance.
Preferences Background in quality management and clinical research.
Details Requisition Number: PRN43973B
Full Time or Part Time: Full Time
Work Schedule Summary: Hybrid remote/in-office
Department: 00870 - Ophthalmology-Research
Location: Campus
Pay Rate Range: $85,000 - $105,000
Close Date: 4/7/2026
Open Until Filled: Yes
#J-18808-Ljbffr