Hybrid Regulatory Affairs Coordinator - Oncology Trials

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Wellness program

Health savings account

Flexible spending accounts

401(k) retirement plan

Life insurance

Short-term disability insurance

Long-term disability insurance

Employee Assistance Program

Paid time off

Holiday pay

Tuition reimbursement

Employee-paid critical illness and/or?

Job summary

Rocky Mountain Cancer Centers in Denver is seeking an experienced Regulatory Affairs Coordinator to oversee regulatory and administrative activities for clinical trials. The role supports QA initiatives, regulatory submissions, and site documentation with a focus on compliance and accuracy.

The position offers a hybrid work schedule with onsite presence two days per week; candidates must reside in the Denver Metro area to enable in-person collaboration and business needs.

Qualifications

• Associate's degree is required; bachelor's in clinical/scientific field preferred.
• Minimum seven years of experience in clinical research, regulatory affairs, or oncology.
• Experience with Phase 1–4 trials and regulatory documentation is ideal.
• Strong regulatory/compliance knowledge and QA familiarity.

Responsibilities

• Track and complete protocol feasibility questionnaires and collect regulatory documents.
• Maintain Protocol Regulatory Documents per SOPs and US Oncology standards.
• Coordinate scheduling and setup for audits and site visits.
• Communicate regulatory issues to staff, management, and investigators.
• Prepare Informed Consent Documents and regulatory packets.
• Coordinate IRB submissions and SAEs reporting.
• Facilitate training on regulatory processes and QA initiatives.
• Support process improvements and cross-functional collaboration.

Skills

Excellent communication

Multi-tasking

Time management

Interpersonal skills

Attention to detail

Regulatory knowledge

Regulatory process training

Education

Associate's degree required

Bachelor's degree preferred

Tools

Microsoft Office

Job description

Rocky Mountain Cancer Centers in Denver is seeking an experienced Regulatory Affairs Coordinator to oversee regulatory and administrative activities for clinical trials. The role supports QA initiatives, regulatory submissions, and site documentation with a focus on compliance and accuracy.

The position offers a hybrid work schedule with onsite presence two days per week; candidates must reside in the Denver Metro area to enable in-person collaboration and business needs.