Clinical Project Manager

Job description

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine, The Cancer Center

Clinical Project Manager (Research Services Manager)

Position #782541 – Requisition #20797

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

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 Cancer Center has an opening for a full-time University Staff (unclassified) Clinical Project Manager 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, headquartered 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 care sites are UCHealth University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report.

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 300 researchers and physicians at three state universities and three healthcare delivery institutions.

Nature of Work:

The Clinical Research Project Manager is responsible for overseeing the protocol opening process to ensure 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.

Professional Field

Medical/Clinical Research

Supervision Received 

Sr. Project Manager

Supervision Exercised

none

Examples of Work 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, implement and maintenance of University of Colorado
• Takes responsibility for meeting internal and external timelines.
• Attends clinical team meetings and SIV visits as necessary.
CCTO Cancer Center Policies and Procedures in relation to conducting multiple clinical research trials and GCP.
• 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.
• 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.
• Reviews budget and collaborates with budget specialist as needed during start-up.
• Helps facilitate the 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.

Salary and Benefits:

The salary range (or hiring range) for this position has been established at $62,985 - $80,117.  

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: 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 [email protected].

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.

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.  Substitution: Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.A minimum of 4 years’ clinical research experience

Required: Applicants must meet minimum qualifications at the time of hire.

Conditions of Employment:

Certification is required either at the time of application or 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:

• Minimum of 2 years’ Oncology experience (clinical or research)
• Minimum of 5 years’ clinical, research or clinical research experience
• Experience working with Cancer Therapy Evaluation Program and PI initiated studies
• 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 terminologyDemonstrates the quick ability to learn, interpret and master complex protocol information.Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology

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

Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Apr 5, 2021
Unposting Date: Apr 18, 2021, 11:59:00 PM

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