Hybrid Regulatory Affairs Coordinator - Clinical Trials

US Oncology Inc.; Denver (CO); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health, dental, and vision plans

Wellness program

Health savings account

Flexible spending accounts

401(k) retirement plan

Life insurance

Long-term disability insurance

PTO and holidays

Tuition reimbursement

Employee assistance program

Job summary

Rocky Mountain Cancer Centers in Denver, CO is seeking an experienced Regulatory Affairs Coordinator to oversee regulatory and administrative activities for clinical trials. The role requires ensuring compliance with SOPs, GCP, and regulatory guidelines across site activities.

You will collaborate with investigators and staff to manage regulatory documents, coordinate audits, and support submissions to IRBs and sponsors, while training teammates and improving QA processes.

Qualifications

• Associate's degree required; Bachelor's preferred in a clinical or scientific discipline.
• Minimum seven years of experience in clinical research or regulatory affairs.
• Experience with Phase 1-4 trials and regulatory documentation (IRB submissions).
• Experience working with Sponsor Monitor representatives and regulatory contacts.

Responsibilities

• Track protocol feasibility and coordinate critical document collection for trial openings.
• Maintain regulatory documents in compliance with SOPs.
• Coordinate audits and start-up/close-out visits.
• Communicate regulatory issues to staff and investigators.
• Prepare informed consent documents and regulatory packets for submissions.
• Facilitate IRB submissions and adverse event reporting.

Skills

Excellent communication skills

Multitasking

Time management

Interpersonal skills

Attention to detail

Adaptability to fast-paced environment

Education

Associate's degree

Bachelor's degree preferred

Tools

Microsoft Office

Job description

Rocky Mountain Cancer Centers in Denver, CO is seeking an experienced Regulatory Affairs Coordinator to oversee regulatory and administrative activities for clinical trials. The role requires ensuring compliance with SOPs, GCP, and regulatory guidelines across site activities.

You will collaborate with investigators and staff to manage regulatory documents, coordinate audits, and support submissions to IRBs and sponsors, while training teammates and improving QA processes.