Regulatory Affairs Coordinator - Cancer Trials (Hybrid)

University of Colorado Anschutz; Aurora (CO); Hybrid; USD 53,000 - 79,000; Full time

Benefits offered by this job

Hybrid schedule

Excellent benefits

Tuition benefit

ECO Pass

Job summary

The University of Colorado Anschutz Medical Campus is seeking a Regulatory Affairs Coordinator to manage regulatory submissions, document preparation, and communication across clinical trial teams. This role handles Form 1572, disclosures, continuing reviews, amendments, and safety reporting with a focus on GCP, FDA regulations, and applicable policies.

Hybrid work 3 days per week on campus with in-person meetings as needed.

Qualifications

• Education: Bachelor’s Degree in any field from an accredited college or university.
• Work Experience: One or more years of professional medical, clinical and/or research experience.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year-for-year basis.
• An advanced degree 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.
• Required for RAC I: Condition of Employment - 5 CEUs

Responsibilities

• Serves as regulatory contact person for ongoing clinical research studies
• Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting
• Works with clinical team to ensure protocols move through our complex process quickly
• Drafts or revises informed consent and HIPAA documents
• Prepares, submits, and tracks regulatory applications, amendments, continuing reviews, consent documents, and other required study documentation
• Reviews, submits, and files CIOMS, SUSARS, Line-listings, IND and other safety reports as needed
• Coordinates submissions to applicable regulatory and institutional review bodies and ensures compliance with required timelines and approval requirements

Skills

Attention to detail

Communication skills

Regulatory knowledge

Time management

Problem solving

Planning & organizing

Education

Bachelor's Degree in any field

Advanced degree (Masters/Doctorate) in related field

Tools

MS Outlook

MS Word

MS Excel

Job description

The University of Colorado Anschutz Medical Campus is seeking a Regulatory Affairs Coordinator to manage regulatory submissions, document preparation, and communication across clinical trial teams. This role handles Form 1572, disclosures, continuing reviews, amendments, and safety reporting with a focus on GCP, FDA regulations, and applicable policies.

Hybrid work 3 days per week on campus with in-person meetings as needed.