OCRST Quality, Education and Outreach Manager
University of Colorado Denver l Anschutz Medical Campus
The University of Colorado Cancer Center
OCRST Quality, Education and Outreach Manager
Position # 00744968 - Requisition 13261
* 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) OCRST Quality, Education and Outreach 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
As a senior member of the Oncology Clinical Research Support Team (OCRST), the Quality, Education and Outreach Manager is accountable for providing management and oversight for LAPS, Education, QA/QC and data reporting program areas. This position is responsible for supporting data reporting needs for Cancer Center Support Grant (CCSG), the Lead Academic Participating Site (LAPS) U10, and the NCI Early Phase I and Phase II UM1 grants. The incumbent is responsible for overseeing and supervising assigned OCRST Program staff and ensuring completion of projects and tasks. This position communicates appropriately and effectively with study investigators, Cancer Center leadership, institutional research leaders and departments, and other team members; has outstanding customer service skills and participates in ongoing efforts to improve clinical research and data reporting practices, procedures, and workflows. This position will assist Oncology Clinical Research Support Team (OCRST) Program Director and Cancer Center leadership in developing and overseeing ongoing quality assurance and quality control procedures and activities relevant to multiple areas of activity, and in developing metrics and analytics that measure progress and success in the Cancer Center's clinical research portfolio.
Examples of Work performed
- Supervise and provide leadership to Education Development Coordinator, LAPS coordinator and data analytics and reporting staff ensuring operations are in compliance with program goals and with FDA, NCI and other applicable federal guidelines
- Assists in the development, implementation and maintenance of University of Colorado Cancer Center Policies and Procedures guidelines, job aids or other documentation as related to assigned program areas; participates in SOP Workgroup and Education Workgroup
- Define program priorities in consultation with Program director and other clinical research managers and leaders; Analyze current processes and procedures to identify strategies to enhance central support for assigned program areas across UCCC Consortium members -including development of new positions as needed
- Participate in meetings with Principal Investigators, clinical research staff, administrators and others across the Cancer Center Consortium to gain an understanding of the nature of the program(s) supported and assist Program Director with development of infrastructure and processes to support CPDM (OCRST) aims and goals
- Oversee a quality assurance/quality control program to ensure accuracy and completeness of clinical trial data in Clinical Trial Management System (OnCore) in compliance with Cancer Center expectations and requirements
- Collaborate across Cancer Center and UCD (including but not limited to Clinical Research Administration Office (CRAO) and OnCore Support team) to improve OnCore system knowledge and usage
- Establish and oversee education activities related to Cancer Center specific topics and needs including but not limited to OnCore training and expectations
- Assist in efforts to expand clinical trial opportunities to community practices in catchment area including LAPS studies, may include site visits and participating in site feasibility assessment activities
- Collaborate with OCRST Program Director and Senior Finance Professional in assessing workloads, staffing needs and makes recommendations as appropriate for assigned program areas
- Participate in and oversee activities related to the collection, interpretation and analysis of clinical trial data relevant to various sponsored research program requirements (e.g. the LAPS U10 grant; the Early Phase UM1 grant; UM1 Phase II supplement grant, the CCSG; etc)
- Support reporting and QA needs as related to NCI's Clinical Trials Reporting Program (CTRP) system, ClinicalTrials.gov, CCSG, LAPS and UM1 grant requirements.
- Willingly accepts additional responsibilities and duties as assigned by management. Performs other related duties and procedures, including special projects, as directed.
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.
- Graduation from an accredited college or university with a bachelor's degree in Business, Biology, Chemistry, Behavioral Science, Health Science, Nursing or related discipline
- Five (5) years professional experience in clinical research. Clinical research experience should include duties related to operations, data management and quality, education/training and/or compliance.
- Two (2) years personnel management experience.
- Experience with data quality and quality assurance activities and practices
- Experience with clinical trial management systems such as OnCore®
- Experience working in an academic institution
- Experience working with NCI, industry and Investigator Initiated clinical trials
- Experience providing mentorship and training
- Experience reviewing/creating/revising policies and procedures
- Knowledge of basic human anatomy, physiology, and medical terminology
- Oncology experience
Knowledge, Skills and Abilities
- Possesses advanced 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
- Demonstrate the quick ability to learn, interpret and master complex protocol information
- Solutions oriented - able to understand complex problems, troubleshoot problems and reverse engineer reporting objectives
- Ability to present complex information in an understandable and compelling manner
- Familiarity with terminology and processes associated with the conduct of clinical research
- Ability to collaborate effectively in a team environment on multifaceted projects
- Ability to work independently and manage priorities so that projects are completed efficiently and effectively.
- Ability to communicate effectively and with a high level of professionalism across various stakeholders
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 Amanda Beyer-Purvis at [email protected]
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 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 April 30, 2018.. Those who do not apply by April 30, 2018 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
Posting Date: Apr 16, 2018
Closing Date: Ongoing
Posting Contact Name: Amanda Beyer-Purvis
Posting Contact Email: [email protected]
Position Number: 00744968