Description
University of Colorado | CU Anschutz Medical Campus
School of Medicine, The Cancer Center, Lung Cancer Early Detection/Prevention Trial Team
Lung Cancer Early Detection/Prevention Team Manager (Research Services Manager)
Position #604930– Requisition #19603* Applications are accepted electronically ONLY at
www.cu.edu/cu-careers *The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.
The Cancer Center has an opening for a full-time University Staff (unclassified) Lung Cancer Early Detection/Prevention Team Manager (Research Services Manager) position.The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care.
Read CU Anschutz Quick Facts here. Nature of WorkThe University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It 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 care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report. 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 includes six institutional partners made up of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.The CU Cancer Center’s vision is to “prevent and conquer cancer.
Together.” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”The Manager is responsible for the implementation and conduct of clinical research trials focused on lung cancer early detection/prevention and for the oversight of the research staff assigned to the program.
Examples of Work PerformedProgram Management
- Responsible for promoting quality research by implementing good clinical practices to insure study flow and adherence to all governing regulations.
- Plans and directs investigator and coordinator meetings (i.e. Initial orientations, study audits, closeout visits, physician meetings, research team meetings) or delegates responsibility to team members as appropriate
- Acts as an inter-institutional and inter-departmental liaison for all regulatory, administrative and staff issues at the various organizations and with all departments involved in the conduct and/or oversight of clinical research. Organizations include, but are not limited to, the Rocky Mountain Regional VA Medical Center, the VA affiliated non-profit research corporation Denver Research Institute, University of Colorado Hospital and affiliated medical centers, and University of Colorado AMC. Departments include, but are not limited to, the CU Cancer Center Administrative Office, the CU Tissue Biorepository, Colorado Multiple Institutional Review Board (COMIRB), and Grants and Contracts.
Regulatory Oversight
- Responsible for the regulatory filings and compliance for all studies within the lung cancer early detection/prevention trial portfolio, including IRB submissions, continuing reviews, FDA filings, and submission of documentation required by study sponsors.
- Manages all protocol amendments or delegates the responsibility as appropriate.
- Participates in preparation for, conduct of, and generation of responses to external audits.
- Participates in preparation for, conduct of, and generation of responses to Data Safety Monitoring 6 month reports.
- Provides guidance regarding FDA and Good Clinical Practice regulation to clinical and investigator staff.
Study Management
- Responsible for the conduct of all clinical study protocols assigned to the team
- Responsible for ensuring team and study compliance with all institutional