Clinical Research

• Responsible for the implementation and conduct of clinical research trials in the Cancer Clinical Trials Office (CCTO)
• 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 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 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
• 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
• 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
• Collaborates with Data Safety Monitoring Committee, Protocol Review Monitoring Committee, and Oncology Clinical Research Support Team
• 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

Clinical Research Manager – GI/GU/Sarcoma

Head and Neck Clinical Research Coordinator

Clinical Research Manager – GI, GU, Sarcoma