University of Utah Health Research · 1 day ago
Associate Director, Clinical Research Quality Assurance Management
Salt Lake City, UT
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$85K/yr - $105K/yr
8+ years expUniversity of Utah Health Research is seeking an Associate Director of Clinical Research Quality Assurance. This role is responsible for the preparation, implementation, and coordination of research projects, ensuring compliance with protocols and regulatory requirements while overseeing quality assurance and quality control of reading center operations.
Higher Education
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
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
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
Preferred
Background in quality management and clinical research
Benefits
The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.
Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.
The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status.
The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106.
Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.
Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work).
Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions.
Company
University of Utah Health Research
At University of Utah Health, our world-class researchers work together to tackle some of the toughest problems in health and medicine.
5001-10000 employees
H1B Sponsorship
University of Utah Health Research 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
2020 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase