Hybrid Regulatory Affairs Coordinator – Open Rank, Entry to Senior

at Oracle

• Job title: Regulatory Affairs Coordinator – Open Rank, Entry to Senior
• Job type: Full Time
• Experience level: Senior
• Salary: $50,996 - $76,814 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Denver, United States

About the role

• Regulatory Affairs Coordinator providing regulatory support for clinical trials and investigator-initiated studies at University of Colorado. Collaborating with leadership and investigators to ensure compliance.

Responsibilities

• Provides regulatory support for clinical trials and investigator-initiated studies for the Division of Hematology.
• Works closely with the HCTU Leadership Team, Principal Investigators, Industry Sponsor/CRO Representatives, IRBs, and other departments.
• Serves as regulatory contact person for ongoing clinical research studies.
• Submits complete and accurate clinical research applications to all required regulatory bodies.
• Writes clear and accurate subject informed consent documents and HIPAA 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

• Entry Level: 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.
• Intermediate Level: 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.
• Senior Level: 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. Two (2) years clinical regulatory compliance or related experience.
• Preferred Qualifications: Bachelor’s degree in science or health related field. One (1) to three (3) years of clinical research or related experience.
• 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

• 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