University Staff
Description
University of Colorado Anschutz Medical Campus
Department: Cancer Center (Cancer Clinical Trials Office - Regulatory Team)
Working Title: Regulatory Compliance Coordinator (Entry Level)
Position #: 00706187 - Requisition #:
41583
Job Summary:
As a member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position provides professional support for Phase I-IV industry-sponsored pharmaceutical trials, National Clinical Trials Network (NCTN) and Experimental Therapeutics Clinical Trials Network (ETCTN) trials, and investigator-initiated clinical trials. The position supports compliance with Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP), and applicable institutional and regulatory requirements.
This entry-level role supports the regulatory management of lower-complexity or lower-acuity studies, including studies in long-term follow-up and industry studies nearing IRB closure. Responsibilities include preparing, reviewing, completing, and submitting regulatory documents; coordinating regulatory monitoring visits and audit activities; maintaining study and personnel information in Advarra OnCore and eReg; supporting investigator onboarding; assisting with NCTN, CTSU, CIRB, and CTEP activities; and coordinating study archiving. Work is performed in collaboration with Regulatory Affairs team members and the Regulatory Affairs Manager.
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:
Clinical Trial Compliance, Monitoring, and Auditing - 40%
Develops and maintains knowledge of Good Clinical Practice, FDA rules and regulations related to clinical trials, National Institutes of Health (NIH) guidelines, International Council for Harmonisation (ICH) guidelines, and Health Insurance Portability and Accountability Act (HIPAA) requirements related to clinical trials.
Assures adherence to research standards established by the FDA, Office for Human Research Protections (OHRP), UCHealth, NCI, and other applicable regulatory agencies.
Assists with preparation of regulatory documents to support accuracy and compliance with applicable regulations and institutional policies.
Oversees essential document completion through DocuSign in accordance with institutional requirements and 21 CFR Part 11.
Collaborates with Regulatory Affairs Coordinators to support audits and FDA inspections by managing regulatory documents, eBinders, and auditor requests.
Coordinates regulatory monitoring visits for the assigned workload, including scheduling and confirming visits.
Clinical Trial Documentation, Systems, and Study Oversight - 60%
Maintains lower-risk studies in long-term follow-up and industry studies nearing IRB closure.
Assists with new investigator onboarding activities, including completion of documentation and organizing required documentation
Compiles enrollment information for continuing review submissions.
Maintains the Doctors by Disease Site spreadsheet as investigators are onboarded or leave the institution.
Coordinates regulatory study archiving activities to support record retention in accordance with GCP
Assists withClinical Trials Support Unit (CTSU) or lead-site communications and new site investigators.
Maintains knowledge of CIRB and local institutional policies, procedures, and requirements related to Principal Investigator worksheets.
Provides backup coverage during team member absences.
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-art 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 offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22/year (maximum accrual 352 hours)
Sick Days: 15/year (unlimited maximum accrual)
Holiday Days: 10/year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.
To see what benefits are available, please visit:
https://www.cu.edu/employee-services/benefits-wellness
**Qualifications:
Minimum Qualifications:
Education:**
Bachelor's degree in any field from an accredited college or university.
Substitution:
A combination of education and related technical, military, paraprofessional, or professional experience may be substituted for the bachelor's degree on a year-for-year basis.
An advanced degree (Masters or Doctorate) 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 Regulatory Compliance Coordinator: Condition of Employment
The individual must obtain and track continuing education regardless of whether the individual holds an additional certification:
Regulatory Compliance Coordinator - 5 continuing education units per calendar year
Applicants must meet minimum qualifications at the time of application.
Preferred Qualifications:
One year of professional medical, clinical, and/or research experience.
Experience with human subject or clinical research regulations.
Basic knowledge of ICH/GCP Guidelines, FDA regulations, and HIPAA requirements governing clinical research
Experience working in an academic and/or medical environment.
Experience using a clinical trial management system, Advarra eReg, DocuSign, and OneDrive.
Conditions of Employment:
Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future
This position is required to work a hybrid schedule (on-campus, 3 days per week).
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