Regulatory Affairs Coordinator - Hybrid Clinical Trials

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

Benefits offered by this job

Medical, Dental, Vision plans

401(a) employer contributions

Paid time off

Job summary

The Regulatory Affairs Coordinator at the University of Colorado Anschutz Medical Campus plays a pivotal role in regulatory management for Phase I–IV trials. You will draft informed consent, prepare submissions to IRBs and review bodies, and support investigators with regulatory tasks while ensuring FDA and GCP compliance.

The role requires meticulous organization, excellent written and verbal communication, and the ability to coordinate multiple stakeholders.

Qualifications

• Bachelor’s Degree in any field (required).
• 1+ year of professional medical, clinical and/or research experience.
• Advanced degree may substitute for experience.

Responsibilities

• Serves as regulatory contact for ongoing clinical studies.
• Guides reporting of Unanticipated Problems (UAP) or Serious Adverse Events (SAE).
• Prepares and submits regulatory applications, amendments, continuing reviews, and consent documents.
• Drafts informed consent and HIPAA documents.
• Maintains regulatory documentation and study milestones in tracking systems.

Skills

Regulatory knowledge

Communication skills

Attention to detail

Regulatory submissions

Education

Bachelor’s Degree in any field

Advanced degree (Masters or Doctorate) in related field

Tools

MS Outlook

MS Word

MS Excel

Job description

The Regulatory Affairs Coordinator at the University of Colorado Anschutz Medical Campus plays a pivotal role in regulatory management for Phase I–IV trials. You will draft informed consent, prepare submissions to IRBs and review bodies, and support investigators with regulatory tasks while ensuring FDA and GCP compliance.

The role requires meticulous organization, excellent written and verbal communication, and the ability to coordinate multiple stakeholders.