Regulatory Affairs Coordinator (Open Rank)
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Key details
- Location
- Multiple Locations
- Work style
- Hybrid
- Level
- Mid level
- Function
- Legal & Compliance
- Focus area
- other
- Posted
- 2d ago
Skills
About the role
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
Additional Duties for RAC II
Additional Duties for RAC III
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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.
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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 offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness
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