Regulatory Trials Coordinator (Entry Level) — Hybrid

University of Colorado Anschutz; Aurora (CO); Hybrid; USD 53,000 - 67,000; Full time

Benefits offered by this job

Medical: Multiple plan options

Dental: Multiple plan options

Disability insurance

Life insurance

Vision insurance

401(a) Plan: Employer contributes 10%

Paid Time Off: Accruals over the year

Vacation Days: 22/year

Sick Days: 15/year

Holiday Days: 10/year

Tuition Benefit: Employees have access

Job summary

The University of Colorado Anschutz Medical Campus is seeking an Entry Level Regulatory Compliance Coordinator to support FDA/GCP compliance for cancer clinical trials. You will prepare regulatory documents, coordinate audits, and maintain trial records in OnCore and eReg, collaborating with the Regulatory Affairs team.

Ideal candidates will have a Bachelor's degree and familiarity with clinical research regulations.

Qualifications

• Bachelor’s degree from an accredited college or university.
• Experience with human subject or clinical research regulations preferred.
• Knowledge of ICH/GCP guidelines, FDA regulations, and HIPAA governing clinical research.

Responsibilities

• Prepare, review, complete, and submit regulatory documents.
• Coordinate regulatory monitoring visits for audits and inspections.
• Maintain study and personnel information in Advarra OnCore and eReg.
• Assist with investigator onboarding and CTSU/CTEP activities.
• Maintain CIRB knowledge and local policies; provide backup coverage.

Skills

Analytical skills

Attention to detail

Complex problem solving

Communication skills

Interpersonal skills

Customer service

Adaptability

Planning and organizing

Technical skills

Education

Bachelor’s degree

Tools

Advarra eReg

DocuSign

OneDrive

Clinical trial management system

Job description

The University of Colorado Anschutz Medical Campus is seeking an Entry Level Regulatory Compliance Coordinator to support FDA/GCP compliance for cancer clinical trials. You will prepare regulatory documents, coordinate audits, and maintain trial records in OnCore and eReg, collaborating with the Regulatory Affairs team.

Ideal candidates will have a Bachelor's degree and familiarity with clinical research regulations.