University of Colorado Anschutz Medical Campus

Department: Cancer Center - Cancer Clinical Trials Office

Job Title: Clinical Research Manager

Position #: 00627298 - Requisition #: 39215

Job Summary:

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% 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% 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 pr