University of Utah ยท 11 hours ago
Clinical Research Coordinators
Salt Lake City, UT
Full-time
Hybrid
Entry, Mid, Senior Level
2+ years expThe University of Utah is seeking a Clinical Research Coordinator in the Department of Pediatrics, Division of Medical Genetics. The role involves coordinating day-to-day clinical trial activities and ensuring adherence to Good Clinical Practices, study protocols, and applicable regulations while working directly with study participants and families.
Higher Education
Responsibilities
Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations
Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care
Create and maintain tools and documentation to track study metrics, providing updates to management
Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities
Maintain source documents and report adverse events
Recruit, screen, enroll, and obtain consent from study participants
Collect and maintain patient and laboratory data
Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies
Work under the direction of the Primary Investigator (PI)
Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor
Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines
Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety
Determines length of visits and coordinates related facility and equipment availability
Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor
Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor
Completes, audits, corrects CRFs, relays CRFs to sponsor
Maintains documents as required by FDA guidelines
Ensure proper collection, processing and shipment of specimens
Qualification
Required
Must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work
Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations
Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care
Create and maintain tools and documentation to track study metrics, providing updates to management
Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities
Maintain source documents and report adverse events
Recruit, screen, enroll, and obtain consent from study participants
Collect and maintain patient and laboratory data
Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies
Work under the direction of the Primary Investigator (PI)
Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor
Attends and participates in Investigator and staff meetings
Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety
Determines length of visits and coordinates related facility and equipment availability
Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor
Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor
Completes, audits, corrects CRFs, relays CRFs to sponsor
Maintains documents as required by FDA guidelines
Ensure proper collection, processing and shipment of specimens
Requires a bachelor's (or equivalency) + 2 years of directly related work experience or a master's (or equivalency) degree
Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience
Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience
Preferred
Prior clinical research experience preferred
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; attention to detail; and the ability to function independently
Excellent interpersonal and communications skills, both oral and written
Proficiency in Microsoft Office and ability to learn new software programs
Benefits
Excellent health care coverage at affordable rates (see the Summary Comparison for more information)
14.2% retirement contributions
Generous paid leave time
11 paid Holidays per year
50% tuition reduction for employees, spouses, and dependent children
Flex spending accounts
University provided basic employee life insurance coverage equal to a salary of up to $25,000
Variety of elective insurance coverage, including life insurance, short and long-term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet.
Free transit on most UTA services
Employee discounts on a variety of products and services, including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
Professional development opportunities
Company
University of Utah
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.
10001+ employees
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 StageLeadership Team
Allison Nicholson
Special Assistant to CFO
Bruce Hunter
Interim Chief Innovation and Economic Engagement Officer
Recent News
National Institutes of Health (NIH)
2023-06-27
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