The Department of Urology is seeking a Lead Clinical Research Coordinator to oversee clinical research operations for a portfolio of investigator-initiated and industry-sponsored studies. This role will provide both hands-on coordination of complex trials and day-to-day supervision of research staff. The Lead Coordinator will ensure regulatory compliance, optimize workflows, and serve as a primary liaison between investigators, sponsors, and institutional partners. Prior experience managing trials and mentoring junior staff is required.

Supervises clinical research staff and performs human resource actions. Prepares professional research documents, applications, manuscripts, and research papers; assists with complex research papers; and oversees Institutional Review Board (IRB) applications. Coordinates multiple, simultaneous research studies and audits research studies. Negotiates contracts, maintains budgets and expenditures, and orders supplies.

• Oversee the daily conduct of clinical trials in compliance with Good Clinical Practice (GCP), IRB requirements, and institutional policies.
• Coordinate study start-up activities, including IRB submissions, budget development, contract review, and sponsor communications.
• Lead patient screening, enrollment, consent, and follow-up processes for active studies; assist team members in managing study visits and data collection.
• Review and approve documentation including source data, case report forms, and regulatory binders to ensure completeness and accuracy.
• Serve as primary point of contact for external sponsors, CROs, and auditors; facilitate site qualification, monitoring, and closeout visits.
• Supervise and mentor research coordinators, assistants, and trainees; provide onboarding and ongoing training on study conduct and compliance.
• Track study metrics (accrual, timelines, deviations, financials) and generate reports for investigators and department leadership.
• Support the preparation of grants, abstracts, and publications as appropriate.
• Work collaboratively with clinical teams to integrate research activities into clinical workflows.

Must be able to sit or stand for prolonged periods of time.