Clinical Trials Regulatory Coordinator - Entry Level (Hybrid)

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

Benefits offered by this job

Medical insurance

Dental options

Disability insurance

Life insurance

Vision insurance

401(a) retirement plan

Paid time off

Vacation days

Sick days

Holiday days

Tuition benefit

ECO Pass

CU Advantage

Job summary

University of Colorado Anschutz Medical Campus is seeking an Entry Level Regulatory Compliance Coordinator to support FDA, GCP, and institutional regulatory requirements for cancer clinical trials. The role involves preparing regulatory documents, coordinating audits, and maintaining trial documentation in systems like Advarra OnCore and eReg.

This hybrid position emphasizes strong organization, communication, and collaboration with the Regulatory Affairs team to ensure compliance across Phase

Qualifications

• Education: Bachelor's degree in any field from an accredited college or university.
• Substitution: A combination of education and related experience may be substituted for the bachelor’s degree on a year-for-year basis.
• An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.

Responsibilities

• Clinical Trial Compliance, Monitoring, and Auditing - Develops and maintains knowledge of GCP, FDA rules and regulations.
• Assists with preparation of regulatory documents to support accuracy and compliance with regulations.
• Oversees essential document completion through DocuSign and 21 CFR Part 11.
• Collaborates with Regulatory Affairs Coordinators to support audits and FDA inspections.
• Coordinates regulatory monitoring visits for the assigned workload.

Skills

Medical/clinical experience

Clinical research regulations

ICH/GCP knowledge

Academic/medical environment

Clinical trial management systems (Ad

Education

Bachelor’s degree in any field

Advanced degree (Masters/Doctorate) related to work

Tools

DocuSign

Advarra eReg

OneDrive

Job description

University of Colorado Anschutz Medical Campus is seeking an Entry Level Regulatory Compliance Coordinator to support FDA, GCP, and institutional regulatory requirements for cancer clinical trials. The role involves preparing regulatory documents, coordinating audits, and maintaining trial documentation in systems like Advarra OnCore and eReg.

This hybrid position emphasizes strong organization, communication, and collaboration with the Regulatory Affairs team to ensure compliance across Phase