National Clinical Trial Network (NCTN) Program Coordinator – Hybrid

University of Colorado CU Anschutz Medical Campus

School of Medicine Cancer Center

National Clinical Trial Network (NCTN) Program Coordinator

Research Services Professional (Intermediate or Senior)/Clinical Sciences

Position #00703383 – Requisition #27749

This is a hybrid position (75% remote/25% on-campus)

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

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.  Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012—covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

• Anschutz Campus – Exemptions are allowed for medical or religious reasons.
• Denver Campus – Exemptions are allowed for medical, religious, or personal reasons.
• Consolidated/Central Services Administration – Will follow Anschutz policy on exemptions.

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.

School of Medicine, Cancer Center has an opening for a full-time University Staff (unclassified) Research Services Professional 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 .

The University of Colorado Cancer Center is Colorado’s only National Cancer Institute (NCI) designated Comprehensive Cancer Center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention, and cancer control. 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.” Our more than 300 renowned physicians and researchers conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive tumors who have struggled to find treatment options elsewhere.

The National Clinical Trial Network (NCTN) Coordinator will serve as a member of the NCTN program housed within the Oncology Clinical Research Support Team (OCRST).  This position will support the needs of the NCTN and Lead Academic Participating Site (LAPS) Program at the CU Cancer Center and at affiliated performance sites located throughout Colorado. In collaboration with the NCTN Program Manager, this position will coordinate activities related to new site performance site set up, and act as a resource to affiliate sites to ensure all aspects of trials being conducted at sites follow regulatory as well as clinical compliance. In addition, this position will be responsible for compiling and reporting study and accrual metrics in order to meet grant requirements, coordinate onboarding activities for investigators and staff involved in the conduct of NCTN trials, ensure sites and investigators remain in good standing for continued participation in NCI sponsored clinical research studies,  and coordinate agenda and gather necessary data for the LAPS Executive Committee meeting and other program meetings.

Professional Field: Clinical Research, Project Management

Supervision Received: NCTN Program Manager

Supervision Exercised: None

Examples of Work Performed:

These job descriptions have been designed to indicate the general nature and level of work performed by employees within its classification. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Program Coordinator Level I Duties (Intermediate Professional)

• Assist in coordination of activities of the LAPS Executive Committee including compiling protocol and site-specific information on studies to be reviewed, gather accrual data to be presented, and distribute agenda and meeting materials including minutes to attendees.
• Coordinate necessary activities for new performance site set up in accordance with NCTN/ NCI Cancer Therapy Evaluation Program (CTEP) requirements. Activities may include obtaining CTEP institution codes and Radiation Therapy Facility numbers, managing appropriate LAPS site roster, and ensuring all standards for new sites are met and relayed to the appropriate parties.
• Manage activities related to performance site pharmacies including appropriate set up with PMB (Pharmaceutical Medical Branch of the NCI), submission of pharmacy worksheets to CTEP and ensuring pharmacy staff listings are kept up to date with staff additions and departures.
• Manage Clinical Trial Support Unit (CTSU) database and roster new staff and investigators as they are onboarded to performance sites. Nominate new investigators to SWOG or appropriate research base as applicable.
• Act as Administrator of the NCI Registration and Credentialing Repository (RCR) database of Investigators, Co-Investigators and research staff. Create and submit NCI profiles to Investigators, Co-Investigators and Pharmacists on an annual basis for renewal.
• Maintain NCI Credentials in OnCore. Work with disease teams to ensure that investigator and staff’s NCI profiles do not lapse. Escalate non-compliance with NCI rules and guidelines to the LAPS grant PI and NCTN Manager.
• Assist in coordination of activities of the LAPS Executive Committee including compiling protocol and site-specific information on studies to be reviewed, gather accrual data to be presented, and distribute agenda and meeting materials including minutes to attendees.
• Participate in planning, conduct, and follow up activities related to the Annual NCTN Educational Retreat. Record annual retreat or other educational sessions and adds them to the NCTN website for further distribution, education, and training.
• Responsible for compiling data necessary for LAPS annual reports and competing grant renewal submissions. Data may include accrual data, protocol listings and metrics related to program growth such as site activations, manuscript submissions, and investigator leadership and engagement activities.
• Participate in activities related to accrual monitoring for active NCTN/LAPS studies including regular review of applicable trials, identification of trials that are not meeting accrual goals, and distribution of low accrual notices to PI and study team(s).
• Monitors and submits monthly expectation reports to disease teams to ensure UCCC remains in good standing with the research bases (Alliance, NRG, SWOG and ECOG-ACRIN) and LAPS by coordinating distribution of data expectation and query reports to clinical research staff and following up on delinquent data (>90 day past due).
• Maintain and submit monthly clinical trial pipeline reports for the disease teams to monitor activity on new clinical trials, attend and participate in protocol progress meetings.
• Ensures that the CU Anschutz NCTN website remains up-to-date with relevant changes and updated education materials.
• Assist with collection of materials needed for UCCC Data and Safety Monitoring Committee and National Group sponsor audits.
• Develop, implement, and maintain tracking and reporting tools such as Smartsheets to meet program goals, improve transparency of process and data availability.
• Participate with OCRST and other Cancer Center departments and staff to identify and implement ways to improve procedures and workflows.

Additional Duties for Program Coordinator Level II Duties (Senior Professional):

• Adheres to and conducts all duties related to Program Coordinator Level I
• Independently manages and provides support to more complex tasks and assignments
• Travel to LAPS participating sites to assist with training, conduct compliance monitoring, provide general assistance, and guide audit preparation as needed.
• Coordinate and manage activities related to new investigator and staff onboarding, credentialing, and rostering in accordance with UCCC and NCI requirements 
• Recommends and drafts enhancements to SOP’s, guidance documents or other tools/templates pertinent to NCTN/LAPS Program

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.

Program Coordinator Level I Requirements:

Education: A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, business administration, business, communication, or a directly related field from an accredited institution

Experience: One (1) year of professional level work experience in:

• Clinical research OR
• Healthcare project management/data management experience OR
• Healthcare data analysis experience

Substitution: Work experience in a related field can substitute for the bachelor’s degree on a year for year basis.  Associate degree plus two (2) additional years of related work experience will substitute for the bachelor’s degree. Masters or other graduate degree in a relevant field of study will substitute for the bachelor’s degree.

Preferred Qualifications:

• Oncology clinical research experience; particularly with NCTN or National Group/NCI sponsored trials
• 2 years of clinical research experience

Program Coordinator Level II Requirements:

Education: A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, business administration, business, communication, or a directly related field from an accredited institution

Experience: Two (2) years of professional level work experience in:

• Clinical research OR
• Healthcare project management/data management experience OR
• Healthcare data analysis experience

Substitution: Work experience in a related field can substitute for the Bachelor’s degree on a year for year basis.  Associate’s Degree plus two (2) additional years of related work experience will substitute for the Bachelor’s degree. Masters or other graduate degree in a relevant field of study will substitute for the Bachelor’s degree.

Preferred Qualifications :

• One (1) year experience with NCTN or National Group/NCI sponsored clinical trials
• Familiarity with NCI CIRB, CTSU and CTEP processes and requirements as they pertain to clinical research.
• Clinical Research Certification (CCRC, CCRA, RAC, etc.)
• Experience with grants and/or contracts funded through the National Institutes of Health (NIH)

Competencies, Knowledge, Skills, and Abilities:

• Excellent interpersonal communication including written and verbal, organizational skills, and ability to problem solve and multi-task. Proven track record in problem resolution
• Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH, NCI and ICH guidelines, and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.
• Able to work autonomously with little direct oversight
• Experience with basic computer systems of Microsoft Word, Excel and Outlook

Salary and Benefits:

The salary range (or hiring range ) for this position has been established at:

Intermediate (Level I)      $48,321-$61,464

Senior (Level II)               $52,239-$66,448  

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

The above salary range (or hiring range ) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

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.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity 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 hr.adacoordinator@ucdenver.edu ​.

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.

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by [10 days from posting). Those who do not apply by this date may or may not be considered.