Clinical Research Manager

University of Colorado

2d•$71,244 - $90,622•Hybrid

About The Position

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%25 Leadership, Compliance, and Process Improvement 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%25 Personnel Development and Workload 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%25 Regulatory Coordination and Coverage Serve as a back-up for Regulatory Supervisors for 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. May serve as coverage for Regulatory and Compliance Program Director as needed May serve as back-up to CCTO Regulatory Compliance and Quality Program Manager if needed

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. 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 experience
Two (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)
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
Ability to learn, interpret and master complex protocol information
This position is not eligible for sponsorship now or in the future.

Nice To Haves

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.

Responsibilities

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)
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
Serve as a back-up for Regulatory Supervisors for 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.
May serve as coverage for Regulatory and Compliance Program Director as needed
May serve as back-up to CCTO Regulatory Compliance and Quality Program Manager if needed