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ESSENTIAL FUNCTIONS

• Directs the development and execution of clinical trial activities for multi-center industry sponsored drug trials, including developing and revising study timelines. Engages with Finance for budget development and budget management.
• Serves as liaison to the Principal Investigator, study leadership, sites, vendors and sponsor. Helps coordinate work between entire study team, including clinical trial sites, clinical and research laboratories, study medical monitors, biostatistics core, and data management team. Represents study team in meetings and during training sessions with sites.
• Leads internal study meetings and monitors progress toward meeting team goals and completing action items. Participates in planning external meetings, including development of agenda and meeting materials and may be required to present or report out on action items.
• Mentors, trains, and manages more junior staff as part of a study project team. Provides professional direction within clinical trials coordination team. Oversees study team interactions with study sites.
• Drafts and/or completes internal review of study documents, such as protocols, amendments, study plans, DSMB reports, grant submissions, and annual reports, for review and approval by study leadership. Drafts requests and reports to regulatory agencies, such as IND application, annual IND update to FDA, etc.
• Reviews monitoring reports and works with study monitors to finalize reports. Manages monitoring schedule in coordination with the monitoring team.
• Presents at larger scale external meetings, and well as other professional meetings.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 5 years of relevant experience required
• Master's degree preferred
• Or equivalent combination of education and experience
• Previous personnel/study team management experience preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required
• Strong communication skills, interpersonal skills, attention to detail, and organization skills required

LICENSES AND CERTIFICATIONS

• CCRP - Certified Clinical Research Professional upon hire referred
• Certified Project Management Professional (PMP)-PMI upon hire preferredp

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.