Regulatory Affairs Coordinator (Open Rank)

University of Colorado; United States; Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Excellent benefits

Job summary

The University of Colorado Anschutz Medical Campus, Cancer Center and its Regulatory Affairs team, seeks a Regulatory Affairs Coordinator (Open Rank) to manage regulatory submissions for Phase I–IV trials and ensure compliance with FDA/GCP guidelines. The hybrid role coordinates with multiple review boards and sponsors, delivering timely regulatory documentation.

Ideal candidates will be detail-oriented with strong organizational and communication skills to serve as the central communications

Qualifications

• Drafts or revises informed consent and HIPAA documents.
• Prepares, submits, and tracks regulatory applications and amendments.
• Detail-oriented with strong organizational and communication skills.

Responsibilities

• Serves as regulatory contact person for ongoing clinical 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 as quickly as possible.
• 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.
• Maintains regulatory documentation and study milestones in institutional tracking systems (Advarra OnCore and eRegulatory management system).
• Serves as back up coverage during RAC absences.

Skills

Regulatory affairs

Clinical trials

FDA regulations

GCP

IRB submissions

Documentation

Communication

Tools

Advarra OnCore

eRegulatory management system

PRMS

COMIRB

WCG IRB

CIRB

CTSU

SWOG

NSABP/RTOG/GOG

Job description

University of Colorado Anschutz Medical Campus

Department: Cancer Center - Cancer Clinical Trails Office (Regulatory Team)

Working Title: Regulatory Affairs Coordinator (Open Rank)

Position #: 00683036 - Requisition #: 41584

Job Summary

As an important member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position works with Phase I-IV industry sponsored (Pharmaceutical), Cooperative Group (NCTN) and/ or Investigator initiated clinical trials in accordance with FDA Regulations, Good Clinical Practice (GCP) and applicable guidelines or policies. The successful candidate will be responsible for providing regulatory management and oversight for clinical trials, including drafting informed consent documents; preparing and submitting all study-related regulatory documents (Form 1572, Financial Disclosure forms, continuing review, amendments) to applicable review committees (PRMS, IRB of record, UCHealth Research Administration); and supporting clinical teams with the development and submission of Unanticipated Problems.

In order to succeed in this position, the individual must be detail-oriented and able to demonstrate superior organizational skills in order to successfully track multiple tasks occurring in parallel. This incumbent must be self-motivated to complete tasks quickly and within set deadlines. This position is the 'hub' of communication between and internal stakeholders so superior oral and written communication skills are required.

Key Responsibilities for All Levels

• 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 are moving through our complex process as quickly as possible
• 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. This may include, but not limited to:
• Colorado Multiple Institutional Review Board (COMIRB)
• Western Copernicus Group Institutional Review Board (WCG IRB)
• NCI Central Institutional Review Board (CIRB)
• Protocol Review and Monitoring System (PRMS)
• Navigates applicable NCTN websites:
• Clinical Trials Support Unit (CTSU)
• Southwest Oncology Group (SWOG)
• NRG Oncology (NSABP, RTOG, GOG)
• Maintains regulatory documentation and study milestones in institutional tracking systems (Advarra OnCore and eRegulatory management system)
• Serves as back up coverage during RAC absences

Additional Duties for RAC II

• Assists in the completion of initial Institutional Biosafety (IBC) applications
• Assists in the completion of Single-Patient IND (sIND) processes and Expanded Access Programs
• Provides shadowing of daily tasks for new members of the Regulatory Affairs team

Additional Duties for RAC III

• Completes all required documentation for submissions specific to trials requiring Institutional Biosafety Committee (IBC) oversight
• Completes all required documentation for Single-Patient IND (sIND) processes and Expanded Access Programs
• Assists with training for new members of the Regulatory Affairs team
• Potentially meets with representatives from Food and Drug Administration (FDA) for review of records

Work Location

Hybrid - this role is eligible for a hybrid schedule of #3 days per week on campus and as needed for in-person meetings.

Why Join Us:

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-arc technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

Why work for the University?

• We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University o