Open Rank Regulatory Affairs Coordinator – Entry to Senior

Oracle

Regulatory Affairs Coordinator supporting clinical trials and studies for the Division of Hematology. Collaborating with investigators and regulatory bodies to ensure compliance and successful study execution.

Posted 5/20/2026full-timeAurora • Colorado • 🇺🇸 United StatesSenior💰 $52,860 - $70,833 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.
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.

Requirements

What you’ll need

Entry Level: Bachelor’s degree in any field.
Intermediate Level: Bachelor’s degree in any field. One (1) year clinical regulatory compliance or related experience.
Senior Level: Bachelor’s degree in any field. Two (2) years clinical regulatory compliance or related experience.
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
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.

Benefits

Comp & perks

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: 15/year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service

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Hard Skills & Tools

clinical regulatory complianceGood Clinical Practice (GCP)informed consent documentsHIPAA Authorizationsdata safety monitoringregulatory submissionsregulatory recordsclinical research applicationssafety updatesamendments

Soft Skills

effective communicationcustomer serviceinterpersonal skillsrelationship buildingwriting skillsoral communicationorganizational skillsattention to detailproblem-solvingteam collaboration