Clinical Research

• 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.
• 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.
• 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.
• 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 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.

Clinical Research Manager – GI, GU, Sarcoma

Head and Neck Clinical Research Coordinator

Clinical Research Manager – GI/GU/Sarcoma