Clinical Research Manager (GI / GU / Sarcoma)
The Clinical Research Manager is responsible for the implementation and conduct of clinical research trials in the Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center. This position is responsible for the oversight of all clinical studies and research staff in assigned programs.
Examples of Work Performed :
40% Clinical Trial Management and Administration :
- Oversees 1 to 3 different disease sites at a given time.
- Manages all staff updates in prescribed databases.
- Manages all Protocol Amendments for disease sites and disseminates changes to team (budget, regulatory, and UCH team members) and updates prescribed databases. Promotes quality study flow and ensures all governing regulations are being adhered to. Reviews Medicare Analysis reviews for each new Amendment for applicable disease sites.
- Acts as an interdepartmental liaison with UCH clinic staff (incl. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology).
- Plans and directs investigator and coordinator meetings (i.e. Initial orientations, study audits, closeout visits, physician meetings, research team meetings.) or delegates responsibility to team members as appropriate.
- Works with budget and regulatory specialist on escalation plans with Contract Research Organizations and Sponsors as needed for resolution of outstanding issues (i.e. financial payment, budget updates, and closeout costs.)
- Oversees team schemas as studies are amended for eligibility, cohort changes, additional arms added, and study closeout.
- Participates in cost savings / productivity strategies to meet or improve the department's operational budget; reviews quarterly finance reports for designated clinical research programs and works with the finance team to resolve discrepancies and review account balances on a regular basis. Provides review and corrections to quarterly financial / clinical dashboards.
- Participates in preparation for, conduct of and generation of responses to external audits and FDA Inspections, and Data Safety Monitoring audits.
- 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, amendment changes, and clinical toolkit.
- Assists investigators with miscellaneous tasks as applicable (i.e. team reports, community engagement, full team and PI meetings).
40% Personnel Development and Management :
Works with team Supervisor in regard to all clinical research personnel issues, including hiring, training and addressing performance issues with guidance from Clinical Program Director; conducts quality assurance audits of employee performance, oversees any technical or problem-solving issues as appropriate.Manages workload balance / acuity across multiple teams and assures clinical research staff coverage is adequate to serve the needs of the Cancer Center.Facilitates team building and cohesiveness across multiple disease sites.20% Departmental Process Improvement, Guidance Development, and Collaboration :
Assists in the development implementation and maintenance of SOPs and internal processes.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.Provides guidance regarding FDA and Good Clinical Practice regulation to clinical and investigator staff.Work Location :
Hybrid this role is eligible for a hybrid schedule of at least 3 days per week on campus and as needed for in-person meetings in Aurora, CO.
Why Join Us :
The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear : "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."
Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.
Benefits statement to include in all benefits-eligible positions :
Why work for the University?
We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including :
Medical : Multiple plan optionsDental : Multiple plan optionsAdditional Insurance : Disability, Life, VisionRetirement 401(a) Plan : Employer contributes 10% of your gross payPaid Time Off : Accruals over the yearVacation Days : 22 / year (maximum accrual 352 hours)Sick Days : 15 / year (unlimited maximum accrual)Holiday Days : 10 / yearTuition Benefit : Employees have access to this benefit on all CU campusesECO Pass : Reduced rate RTD Bus and light rail serviceThere are many additional perks & programs with the CU Advantage.
Qualifications :
Minimum Qualifications :
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. Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.Five (5) years' clinical research experienceTwo (2) years' clinical research or health care personnel management experience (can be included in above clinical research experience or can be from another healthcare related position)Preferred Qualifications :
Oncology experience (clinical or research)Experience working simultaneously with various sponsors and studies in multiple phases.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 budgetsUnderstanding 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 terminologyAbility to learn, interpret and master complex protocol information.How to Apply :
For full consideration, please submit the following document(s) :
A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the positionCurriculum vitae / ResumeThree to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to : cole.sprague@cuanschutz.edu
Screening of Applications Begins :
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by October 24, 2025. Those who do not apply by this date may or may not be considered. Hiring department will need to notify their Talent Acquisition Consultant when they want to have the advertisements removed for the posting.
Anticipated Pay Range :
The starting salary range (or hiring range) for this position has been established as HIRING RANGE (minimum 40th posting max). $71,244-$90,622. The above salary