Cancer Center Clinical Trials Office (CCTO) Project Manager

University of Colorado
Published
September 19, 2022
Location
Aurora, CO
Category
Job Type

Description

University of Colorado | CU Anschutz Medical Campus

School of Medicine | Cancer Center

Official Title: Research Services Clinical Science Program Manager

Working Title: Cancer Center Clinical Trials Office (CCTO) Project Manager

Position #00782541- Requisition #27430

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

Denver: 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.

The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu.

The School of Medicine's Cancer Center has an opening for a full-time University Staff (unclassified) Research Services Clinical Science Program Manager position.

Jobs in the Research Services career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Program Managers are responsible for the day-to-day operation of a program, function or work unit, including the Development and implementation of processes consistent with college, school or departmental strategies and processes.

Nature of Work

Clinical Science Program Managers perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Program Managers may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Clinical Science Program Managers independently manage clinical research programs, perform clinical research project management functions and/or supervise clinical research teams of 2 or more FTE. Some Assignments will not move beyond this level.

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.

This Clinical Research Project Manager is responsible for overseeing the protocol opening process to ensure the shortest possible timelines are met for 1 to 3 different disease sites at a given time. Communicating as needed to the Sr. Project Manager of any problems in protocol opening.

This position is 100% remote.

Professional Field

Medical/Clinical Research

Supervision Received

Sr. Project Manager

Supervision Exercised

None

Examples of Duties Performed

* Serves as primary contact person for clinical research studies in start-up and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records. This may include the Food and Drug Administration (FDA).
* Works with regulatory specialist on study submission to PRMS and Research Administration Portal during start-up (this may include amendments prior to Site Initiation Visits).
* Completes OnCore specification and protocol sign-off during start-up.
* Acts as an interdepartmental liaison with UCH clinic staff (incl. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology).
* Plans and directs pre-study qualification visits with Sponsor and/or Contract Research Organization.
* Manages routing of confidentially agreements (CDA) with the Clinical Research Administrations Office (CRAO).
* Manages routing and reviews of contract trial agreements (CTA) with the Clinical Research Administrations Office (CRAO).
* 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 trial budgets.
* Assists in the development, implementation and maintenance of University of Colorado policies and/or guidances
* Takes responsibility for meeting internal and external timelines.
* Attends clinical team meetings and SIV visits as necessary.
* Adheres to CCTO Cancer Center Policies and Procedures in relation to conducting multiple clinical research trials
* Manages all staff updates in OnCore in a timely and accurate manner for 1 to 3 disease sites during study start-up.
* Oversees OnCore calendar reviews and Medicare Analysis Reviews for 1-to 3 disease sites during start-up of a trial.
* Works with budget and regulatory specialist on amendment portal submissions for UCHealth during start-up.
* Reviews budget and collaborates with budget specialist as needed during start-up.
* Submits and manages initial treatment plans through the UCHealth Beacon process and works with assigned RN for completion for 1 to 3 disease sites.
* Manages Internal Protocol Amendment Review forms or delegates responsibility as appropriate for 1 to 3 disease sites during start-up.
* Helps facilitate standard escalation plan with Contract Research Organizations and Sponsors as needed to keep the project moving.
* Adds new trials to disease site schemas
* Adds new trials to VIA oncology platform
* Updates OnCore fields, staff console, and internal trackers in a timely manner.
* Collaborates with Data Safety Monitoring Committee, Protocol Review Monitoring Committee, and Oncology Clinical Research Support Team on initiatives.
* Works with the Oncology Clinical Research Support Team staff on Investigator Initiated Trials reviewing protocol, IIT sign-off, and clinical toolkit.
* Assists investigators with miscellaneous tasks as applicable for start-up.
* Serves as role model to all Cancer Clinical Trial Office staff - remains in compliance with all training requirements, meets established deadlines, possesses a strong understanding of clinical research history, regulations, and ethics.
* Attends and participates in leadership and management courses for growth and skill development.
* Provides guidance regarding FDA and Good Clinical Practice regulation to clinical and investigator staff.
* Performs additional duties as assigned by senior project manager and/or clinical operations director.
* Attends clinical team meetings and SIV visits as necessary.
* Assists in the development, implementation, and maintenance of University of Colorado CCTO Cancer Center policies and procedures in relation to conducting multiple clinical research trials and good clinical practice.
* Manages all staff updates in OnCore in a timely and accurate manner for 1 to 3 disease sites during study start-up.
* Oversees OnCore calendar reviews and Medicare Analysis Reviews for 1-to 3 disease sites during start-up of a trial.
* Manages Internal Protocol Amendment Review forms or delegates responsibility as appropriate for 1 to 3 disease sites during start-up.
* Updates OnCore fields, staff console, and internal trackers in a timely manner .
* Serves as role model to all Cancer Clinical Trial Office staff - remains in compliance with all training requirements, meets established deadlines, and possesses a strong understanding of clinical research history, regulations, and ethics.
* Attends and participates in leadership and management courses for growth and skill development.

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.

Minimum Qualifications

* Bachelor's degree in any field
* A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis

* Four (4) years of clinical research or related experience

Applicants must meet minimum qualifications at the time of hire.

Conditions of Employment

Certification is required within 1 year of hire (one of the below):

* CCRC - Certified Clinical Research Coordinator
* CCRP - Certified Clinical Research Professional
* CCRA - Certified Clinical Research Associate

Preferred Qualifications

* Bachelor's degree in business, health administration, communications, biological or social science, or any other field of study related to the work assignment
* Two (2) years of oncology experience (clinical or research)
* Five (5) years of clinical research or related experience
* Experience working in an academic medical setting
* Experience in teaching, precepting, and mentoring employees to clinical research

Competencies, 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
* Demonstrates the quick ability to learn, interpret and master complex protocol information
* Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology

Salary and Benefits

The salary range (or hiring range) for this position has been established at $62,687 to $79,737.

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.

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.

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

Total Compensation Calculator: 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 [Click Here to Email Your Resumé].

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, persons within the LGBTQ community, 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.

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