Clinical Research Manager

Job description

PURPOSE AND SCOPE: Provides support to Frenova Renal Research and the contract research organization (CRO) by monitoring and tracking the progress of clinical study activity at research sites. Provides support with regulatory agency and sponsor inspections/audits as needed. PRINCIPAL DUTIES AND RESPONSIBILITIES: Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. - Manage clinical research staff including but not limited to: interviewing potential new staff, training of new and existing staff, staff coverage, and team meetings - Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations - Ensure the clinical research project team(s) for a specific trial understands the project objectives, timelines, and tasks - Ensure research project enrollment goals are met according to project timelines - Develop or review study specific site budgets, providing constructive feedback as needed - Review confidentiality disclosure agreements and clinical trial agreements - Monitor and contain site expenses - Review study budget...