University of Colorado · 1 day ago
Regulatory Affairs Coordinator (RAC) (Open Rank, Entry to Senior)
Colorado, United States
Full-time
Hybrid
Entry, Mid, Senior Level
$51K/yr - $76K/yr
1+ years expThe University of Colorado Anschutz Medical Campus is seeking a Regulatory Affairs Coordinator within the Division of Hematology. This role is responsible for providing regulatory support for clinical trials and investigator-initiated studies, ensuring compliance with regulatory requirements throughout the study lifecycle.
EducationHigher EducationUniversities
Responsibilities
Serves as regulatory contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records
Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado. This may include, but is not limited to, the following: Colorado Multiple Institutional Review Board (COMIRB), Protocol Review and Monitoring System (PRMS), Hospital Research Support Services (UCH-RSS), University of Colorado Hospital Biosafety Committee (IBC), University of Colorado Hospital Clinical Trials Research Center (CTRC)
Writes clear and accurate subject informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations
Completes and submits continuing reviews, amendments, and safety updates as needed
Participates in Data Safety Monitoring Committee (DSMC) internal audits
Updates database with regulatory submission and approval dates
Qualification
Required
Bachelor's degree in any field
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
One (1) year clinical regulatory compliance or related experience
Two (2) years clinical regulatory compliance or related experience
Applicants must meet minimum qualifications at the time of hire
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
Ability to communicate effectively, both in writing and orally
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
Outstanding customer service skills
Knowledge of basic human anatomy, physiology, and medical terminology
Ability to interpret and master complex research protocol information
Preferred
Bachelor's degree in science or health related field
One (1) to three (3) years of clinical research or related experience
Benefits
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22/year (maximum accrual 352 hours)
Sick Days: 15/year (unlimited maximum accrual)
Holiday Days: 10/year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service
Company
University of Colorado
University of Colorado offers higher education and serving as the catalysts in business, arts, health, and community growth.
10001+ employees
H1B Sponsorship
University of Colorado 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 (184)
2024 (124)
2023 (163)
2022 (115)
2021 (86)
2020 (95)
Funding
Current Stage
Late StageTotal Funding
$0.5MKey Investors
US Department of EnergyUS Department of Commerce, Economic Development Administation
2023-07-27Grant
2023-01-26Grant
2021-04-06Grant· $0.5M
Leadership Team
Richard Schulick
Professor and Chair of Surgery
Recent News
Sports Business Journal
2025-12-28
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