The Cancer Center Oncology Clinical Research Support Team (OCRST) is responsible for providing central management and oversight for Investigator-Initiated clinical trials at the CU Cancer Center. The Regulatory Affairs Coordinator (RAC) works with investigators and OCRST members in the development and implementation of investigator-initiated clinical trials. This position is responsible for completing regulatory start up and maintenance tasks. The position will also be responsible for submissions to the FDA for IND applications as required for investigator-initiated trials. This position communicates appropriately and effectively with study investigators, other team members, and regulatory bodies such as FDA, COMIRB, UCH RSS; has outstanding customer service skills and participates in ongoing efforts to improve regulatory practices, procedures, and workflow.
EDUCATION: Bachelor’s Degree focused in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration, Law, or related fields of study.
EXPERIENCE: Two (2) or more years of research, regulatory, or compliance experience.
Substitution: Work experience in a related field can substitute for the Bachelor’s degree on a year-for-year basis. Additionally, an Associate’s Degree plus two (2) additional years of related work experience will also substitute for the Bachelor’s degree.
Two years oncology research and/or academic regulatory experience.
Experience with submissions to IRBs, and/or the FDA for IND or IDE.
Experience working with Investigator-Initiated clinical trials.
Experience handling and prioritizing detailed tasks and meeting deadlines.
General understanding of Anatomy, Physiology, and medical terminology a plus.
Internal Number: 15460
About University of Colorado Cancer Center
The University of Colorado Cancer Center, located at the Anschutz Medical Campus, is Colorado’s only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical partner for adult care, University of Colorado Hospital is ranked in the top 15 hospitals nationwide by U.S. News and World Report and Children’s Hospital Colorado is ranked 8th by the same organization in Pediatric Cancer Care. The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center is a consortium of approximately 261 researchers and physicians at three state universities and three clinical institutions, all working toward its vision to prevent and ...cure cancer while being a global model for patient care delivery, interdisciplinary research, and training.