University of Colorado Clinical Research Manager in Aurora, Colorado

University of Colorado Denver l Anschutz Medical Campus

University of Colorado Cancer Center

Clinical Research Manager (Breast)

Position # 00696083 – Requisition 13580



Applications are accepted electronically ONLY at www.cu.edu/cu-careers



/The University of Colorado Cancer Center has an opening for a full-time University Staff (unclassified) Clinical Research Manager position./

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.

_Nature of Work_

The Clinical Research Manager is responsible for the implementation and conduct of clinical research trials in the Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center. This position is responsible for the oversight of all clinical studies and research staff in assigned programs.

_Examples of Work Performed_

  • Works with team Supervisor in regards to all clinical research personnel issues, including hiring, training and addressing performance issues with guidance from Senior Research Operations Manager; conducts quality assurance audits of employee performance, oversees any technical or problem solving issues as appropriate.

  • Assists in the development of standard practices for department based on GCP guidelines and oversees implementation of practices among teams.

  • Acts as an interdepartmental liaison with UCH clinic staff (incl. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology).

  • Plans and directs investigator and coordinator meetings (i.e. pre-study qualification visits, initial orientations, study audits, and closeout visits.) or delegates responsibility to team members as appropriate

  • Performs pre-reviews of all regulatory documents prior to IRB submission to promote quality study flow and ensure that all governing regulations are being adhered to.

  • Participates in cost savings/productivity strategies to meet or improve the department's operational budget; reviews monthly finance reports for designated clinical research programs and works with the finance team to resolve discrepancies and review account balances on a regular basis.

  • Assures clinical research staff coverage is adequate to serve the needs of the Cancer Center.

  • Participates in preparation for, conduct of and generation of responses to external audits.

  • Oversees the protocol opening process to ensure shortest possible timelines are met, assists as needed and informs Operations manager of any problems in protocol opening

  • Assists in the development, implement and maintenance of University of Colorado CCTO Cancer Center Policies and Procedures in relation to conducting multiple clinical research trials

/This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority./

_Salary and Benefits_

The hiring salary for this position is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.

The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services.

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.

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.

_Minimum Qualifications_

  • Bachelor's Degree in Science, Health, Nursing, Business or other related field.

  • 5 years’ clinical and/or research experience.

  • 2 years’ personnel management experience.

  • /Substitution:/A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis, but not for the specific experience.

_Conditions of Employment:_

  • /Certification & Licensure Required: /Current HIPPA and GCP training (must have within 30 days of hire); current Clinical Research Certification (CCRC, CCRA, CCRP)OReligible and willing to sit for next exam; must have certification within one year of employment. Failure to complete the certification requirement within one year may be cause for termination.

_Preferred Qualifications_

  • Oncology experience (clinical or research)

  • Experience working simultaneously with various sponsors and studies in multiple phases

  • Experience working in an academic medical setting

  • Experience in teaching, precepting and mentoring employees to clinical research

_Knowledge, Skills, and Abilities _

  • Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.

  • Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.

  • Knowledge of research study budgets

  • Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications. Examples of work include creating treatment care plans for submission, utilizing workload management tools, and implementation or use of CTMS programs.

  • 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 basic human anatomy, physiology, and medical/pharmaceutical terminology

Job: *Research Services

Organization: *H0001 -- Anschutz Medical Campus

Title: Clinical Research Manager

Location: Aurora

Requisition ID: 13580