University of Utah Health Research · 13 hours ago
PS Regulatory Coordinator
Salt Lake City, UT
Full-time
Onsite
Entry Level
$39K/yr - $68K/yr
2+ years expUniversity of Utah Health Research is seeking a PS Regulatory Coordinator in the Department of Pediatrics, Division of Pediatric Neurology. This role involves developing and coordinating the submission of regulatory documents to ensure compliance with governing requirements, while overseeing research study documents in an administrative and operational capacity.
Higher Education
Responsibilities
Supports all aspects of regulatory compliance
Prepares regulatory documents, including consent forms for submission to research review committees
Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions
Tracks study approvals and expirations to ensure uninterrupted project approval
Tracks sponsor and investigator-initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board ( IRB )
Submits study start-up applications, renewal applications and study progress reports to the IRB
Coordinates with study sponsor, investigator and IRB to complete study closure activities
Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission
Recommends and implements regulatory process improvements
Maintains current knowledge of federal and institutional guidelines and requirements governing research
Maintains regulatory database
Generates ad hoc reports as requested
Qualification
Required
Bachelor's degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required
demonstrated human relations and effective communication skills also required
This position is patient-sensitive and must fulfill all associated requirements
We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy
Preferred
One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred
Three or more years of industry sponsored clinical trials experience is preferred
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; extensive understanding of research procedures
Experience with Medical Record Coding, familiarity with EMR and medical record structure and data location, proficiency in computers and software applications (MS Access), detail oriented, critical thinking skills is preferred
Self-motivated and flexible
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 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
Funding
Current Stage
Late StageCompany data provided by crunchbase