CCTO PhaseI/GI Clinical Research Supervisor




University of Colorado Denver

University of Colorado Cancer Center

Cancer Clinical Trial Office

CCTO Phase I/GI Clinical Research Supervisor

Position # 00735479 - Requisition 10139

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

The University of Colorado Cancer Center, Cancer Clinical Trials Office has an opening for a full-time University Staff (unclassified) Phase I/GI Clinical Research Supervisor 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 25 by U.S. News and World Report for cancer care 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 400 researchers and physicians at three state universities and three clinical institutions, all working toward one goal: Translating science into life.

Job Summary

The Cancer Clinical Trials Office (CCTO) is looking to hire a full time Clinical Research Supervisor for the Phase I/GI team. This position oversees clinical studies performed at the CU Cancer Center and directly supervises the clinical research staff.

Examples of Work Performed

  • Arranges orientation and provides training, supervision and leadership to the clinical research staff.
  • Assists clinical research staff with technical issues, problem solving and intervention when appropriate; delegates responsibility for elements of the conduct of selected clinical trials.
  • Acts as an interdepartmental liaison with UCH clinic staff (i.e. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology).
  • Plans and directs investigator and coordinator meetings including but not limited to pre-study qualification visits, initial orientations, study audits, and closeout visits.
  • Responsible for all clinical research personnel issues, including performance evaluations, counseling, and disciplinary actions with guidance from Clinical Research Manager.
  • Work with finance team members to resolve discrepancies and to review account balances on a regular basis.
  • Participate in external audits and internal process improvement strategies to promote consistent best practices.
  • Assures compliance with all protocol details which includes ensuring the capture of all data points requested on a protocol-specific basis and ensuring that tests and procedures required by clinical protocols are performed and documented


PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

Salary and Benefits:

The hiring salary for this position is negotiable and commensurate with skills and experience. This position is/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.


Qualifications

Minimum Requirements

  • 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.
  • Two (2) years of clinical, research, and/or clinical research experience.
  • Substitution: Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis, but not for the specific experience.


Conditions of Employment

  • Current Clinical Research Certification (CCRC, CCRA, CCRP) - and/or eligible and willing to sit for next available 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

  • Four (4) years of clinical and/or clinical research experience.
  • One year of oncology research
  • Personnel management experience
  • Experience serving as a primary coordinator for clinical trials
  • Experience teaching, orienting and mentoring new employees to clinical research
  • Experience assisting in the development of policy, procedure or patient education materials related to clinical research


Knowledge, Skills, and Abilities

  • Knowledge of basic human anatomy, physiology, medical terminology
  • Advanced knowledge of GCP, 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
  • Proficient with Clinical Research Coordinator III duties/responsibilities
  • Excellent interpersonal and customer service skills
  • Excellent oral and written communication skills
  • Organization and time management skills
  • Leadership abilities
  • Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with National Cancer Institute (NCI) sponsored, private industry and investigator initiated clinical trials



Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers * REQUIRED APPLICATION MATERIALS: 1). A cover letter/letter of application which specifically addresses the job requirements and outlines qualifications. 2) A current resume/CV. 3) List of 3-5 professional references. Questions should be directed to Mark Morrow at Mark.Morrow@ucdenver.edu.

Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 3-5 references if you are referred to the Hiring Authority for an interview. We will notify you prior to contacting both on and off-list references.

Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:APPLICATION DEADLINE: Applications will be accepted until the position is filled, but full consideration will be given to complete applications received by July 31, 2017. Those who do not apply by July 31, 2017 may or may not be considered.



Job Category: Research Services

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20066 - SOM-U of Colo Cancer Center

Schedule: Full-time

Posting Date: Jul 17, 2017

Closing Date: Ongoing

Posting Contact Name: Mark Morrow

Posting Contact Email: Mark.Morrow@ucdenver.edu

Position Number: 00735479

PI98709322