Associate Director, Clinical Research Quality Assurance Management jobs in United States
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University of Utah ยท 18 hours ago

Associate Director, Clinical Research Quality Assurance Management

University of Utah is seeking an Associate Director of Clinical Research Quality Assurance responsible for overseeing the quality assurance and quality control of reading center operations. The role involves collaboration with various stakeholders to ensure compliance with research protocols and management of clinical databases.

Higher Education
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H1B Sponsor Likelynote

Responsibilities

Quality assurance and quality control of reading center operations. Ensure compliance with protocols, regulatory regulations, and overall objectives. Ensure that all targets, timelines, budgets, and requirements are met.Management of internal Quality Management System, revise and expand internal SOPs (Standard Operational Procedures)
Overview and perform study startup, budgeting and invoicing
Interact with the 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

Qualification

Quality AssuranceClinical ResearchData ManagementRedcap DatabasesSOP DevelopmentAnalytical SkillsCollaborationProblem Solving

Required

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
1 year of higher education can be substituted for 1 year of directly related work experience

Preferred

Background in quality management and clinical research

Benefits

Learn more about the great benefits of working for University of Utah: benefits.utah.edu

Company

University of Utah

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The University of Utah, located in Salt Lake City in the foothills of the Wasatch Mountains, is the flagship institution of higher learning in Utah.

H1B Sponsorship

University of Utah has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (216)
2024 (189)
2023 (201)
2022 (175)
2021 (156)
2020 (174)

Funding

Current Stage
Late Stage

Leadership Team

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Allison Nicholson
Special Assistant to CFO
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Bruce Hunter
Interim Chief Innovation and Economic Engagement Officer
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Company data provided by crunchbase