Lung Cancer Early Detection/Prevention Team Manager
DescriptionUniversity 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
The 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 Performed
- 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.
- 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.
- Responsible for the conduct of all clinical study protocols assigned to the team
- Responsible for ensuring team and study compliance with all institutional requirements regarding the use of OnCore®, the institution’s clinical trial management system. This includes oversight of all steps required to initiate and maintain a protocol within the Oncore system and ensuring all study subjects are correctly registered in OnCore in a timely manner.
- Responsible for assignment of staff to cover trials
- Responsible for insuring conduct of studies and interactions with potential subjects by staff members is appropriate and aligned with all federal, state and organizational rules requirements
- Responsible for all required reporting on unanticipated events, including adverse events and serious adverse events; and on all protocol deviations
- Responsible for appropriate collection, and recording of all clinical data and documentation as required by the protocol
- Responsible for acquiring, and maintaining, active appointments at all trial sites.
- Serves as study liaison with external sponsors and internal offices (Cancer Center Administration, Grants and Contracts, COMIRB) to insure budget and contract negotiations progress smoothly and remain in alignment with the protocol
- Responsible for developing study budgets as needed
- Meets monthly with CU Cancer Center Administrative Office to review study financials and discuss funding availability for completion of studies
- Meets as needed with Dr. Keith to discuss study funding and strategize on how to address potential funding shortfalls
- Responsible for all clinical research personnel assigned to the team including hiring, training and addressing performance issues with guidance from Dr. Keith, the CU Cancer Center Administrative Office, and University Human Resources office.
- Responsible for quality of employee performance and provides appropriate support and direction to assist employees in resolving any issues technical or other issues that arise.
- Manages workload balance/acuity across team members and assures clinical research staff coverage is adequate to serve the needs of the trial portfolio.
- Manages all staff updates in OnCore in a timely and accurate manner.
- Completes OnCore specification and protocol sign-off as appropriate.
- Manages team member vacations, out of office coverage, and the time management of direct reports.
- Develops standard practices for the team based on GCP guidelines and oversees implementation of, and adherence to standard practices.
- Facilitates team building and cohesiveness.
The salary range begins at $62,985.This position is not eligible for overtime compensation.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator: http://www.cu.edu/node/153125Diversity and Equity:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected] The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
- Bachelor’s degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment. Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.
- A minimum of 5 years clinical research experience inclusive of at least 3 years as lead coordinator on Phase I clinical trials
- A minimum of 3 years conducting clinical trials at a VA medical center
- Minimum of 1-year personnel management experience
- The years of experience can be obtained concurrently.
- Certification is required within 6 months of hire (one of the below):
- CCRC – Certified Clinical Research Coordinator
- CCRP – Certified Clinical Research Professional
- CCRA – Certified Clinical Research Associate
- Oncology experience (clinical or research)
- Experience with the OnCore® Clinical Trials Management System
- Experience with early detection/chemoprevention studies
- Experience filing clinical trial regulatory paperwork and recruiting subjects to trials at a VA medical center
- Excellent interpersonal communication, organizational skills, and ability to problem solve and manage multiple different tasks and priorities.
- Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.
- Knowledge of research study budgets
- Understanding of computer systems and proficiency using MS Office Suite.
- Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology
- Able to read, interpret and master complex protocol information efficiently and with a high degree of accuracy.
Job Category: Research Services
Primary Location: Aurora
Posting Date: Nov 19, 2020
Unposting Date: Ongoing