Hybrid Oncology Regulatory Affairs Coordinator

CU Denver; Aurora (CO); Híbrido; USD 53.000 - 79.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Tuition Benefit

ECO Pass

Retirement 401(a) Plan

Descripción de la vacante

The University of Colorado Anschutz Medical Campus is seeking a Regulatory Affairs Coordinator to support the Cancer Clinical Trials Office. You will manage regulatory submissions, draft consent documents, and coordinate reviews across multiple boards for Phase I–IV trials, including INDs and safety reports.

The role emphasizes meticulous regulatory oversight, excellent communication with internal teams, and the ability to track multiple tasks in a fast-paced environment.

Formación

• Bachelor's degree in a related field or equivalent professional experience.
• Two or more years of regulatory or clinical research experience preferred.
• Hybrid schedule with on-campus presence required three days per week.

Responsabilidades

• Serve as regulatory contact for ongoing clinical research studies.
• Guide clinical teams on Unanticipated Problems (UAP) or Serious Adverse Event (SAE) reporting.
• Draft or revise informed consent and HIPAA documents; manage study documentation.
• Prepare, submit, and track regulatory applications, amendments, and continuing reviews.
• Review and file CIOMS, SUSARS, INDs, and safety reports as needed.
• Coordinate submissions to COMIRB, WCG IRB, CIRB, PRMS and other review bodies.

Conocimientos

Analytical Skills

Attention to Detail

Complex Problem Solving

Communication Skills

Interpersonal Skills

Customer Service

Adaptability

Planning and Organizing

Technical Skills

Educación

Bachelor's Degree

Herramientas

MS Outlook

MS Word

MS Excel

Descripción del empleo

The University of Colorado Anschutz Medical Campus is seeking a Regulatory Affairs Coordinator to support the Cancer Clinical Trials Office. You will manage regulatory submissions, draft consent documents, and coordinate reviews across multiple boards for Phase I–IV trials, including INDs and safety reports.

The role emphasizes meticulous regulatory oversight, excellent communication with internal teams, and the ability to track multiple tasks in a fast-paced environment.