Regulatory Affairs Coordinator (Clinical Research)

Location: Hybrid role with onsite work in Denver, Colorado, two days per week. Candidates must reside within the Denver Metro area.

Salary: $65,000–$95,000 per year

Company

Rocky Mountain Cancer Centers is Colorado's largest and most comprehensive provider of cancer care and operates within hirify.global.

What you will do

• Manage regulatory and administrative activities for oncology clinical trials from site qualification through study closeout.
• Track protocol feasibility questionnaires, collect critical documents, and coordinate study start-up activities.
• Maintain protocol regulatory files and prepare informed consent documents and regulatory packets for sponsor and IRB submissions.
• Coordinate local and central IRB submissions, continuing reviews, audits, monitoring visits, and study initiation and closeout visits.
• Report regulatory issues and serious adverse events to appropriate clinical staff, management, investigators, sponsors, the FDA, and IRBs.
• Support process improvement and quality assurance initiatives and train staff on regulatory procedures when needed.

Requirements

• Associate's degree required; a bachelor's degree in a clinical or scientific discipline is preferred.
• At least seven years of experience in clinical research, regulatory affairs, and/or an oncology-related field.
• Experience with Microsoft Office and sponsor monitor representatives.
• Knowledge of Good Clinical Practice, applicable regulations, and clinical research regulatory processes.
• Strong communication, interpersonal, multitasking, time management, and attention-to-detail skills.
• Ability to work onsite in the Denver Metro area two days per week is required.

Culture & Benefits

• Health, dental, and vision insurance plans.
• Wellness program, health savings account, and flexible spending accounts.
• 401(k) retirement plan and life, short-term disability, and long-term disability insurance.
• Paid time off, holiday pay, tuition reimbursement, and employee assistance program.
• Background check and a non-federal drug test are required before hire; the drug test excludes marijuana.
• Work may involve exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations, and other oncology clinic conditions.