As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor’s degree with major course work in field of assignment required.
• 2 years of related work experience involving direct assistance to researchers; or any equivalent combination of experience, training and education required.
• 5 years of experience in human subject research coordination; or an equivalent combination of education and related experience preferred.
• Experience coordinating clinical and/or research activities, managing and supervising staff, working with family caregivers and/or providers, preparing and managing Institutional Review Board documentation preferred.
• Experience with grant progress reports, clinical trial registration, and other regulatory processes preferred.

KNOWLEDGE, SKILLS AND ABILITIES

The ability to work independently, strong written and verbal communication skills and excellent organizational skills with attention to detail and efficiency.
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GENERAL PURPOSE

The Lab Manager supports Dr. Christie Petrenko in coordinating human subject research activities across the dynamic Thrive FASD lab, including multiple NIH-funded clinical trials, student projects, and pilot studies. With minimum direction and considerable latitude for independent judgment, assigns work plans to research staff and students to achieve aims efficiently across projects in the lab. Develops, implements, and evaluates recruitment, information, and data and study management systems. Trains and monitors staff in research policies and practices, professional development, and performance. Manages regulatory paperwork in accordance with human subject IRB, continuing education, clinical trial, and grant agency requirements and timelines. Demonstrates shared values of Mt. Hope Family Center.

ESSENTIAL FUNCTIONS

• Oversees and coordinates human subject research activities across multiple clinical trials and projects in the Thrive FASD lab. Oversees multiple project coordinators, research staff, and students in the lab to ensure aims are achieved. Assigns work plans to achieve aims efficiently across projects in the lab.
• Develops, implements, and monitors systems and methods to ensure quality, efficiency, and consistency in processing human subject research data across the lab. Reviews study progress, including data, finances, documentation, and reporting deliverables.
• Ensures compliance with applicable regulatory and institutional requirements and manages documentation and reporting such as grant progress reports, human subjects’ protocols, trial registration, and continuing education reporting. Implements corrective action when inconsistency of activities is identified.
• Trains and oversees other research staff and students in conducting human subject research specific to study protocols and compliance with Good Clinical Practice guidelines and sponsor requirements. Monitors staff performance and professional development.
• As part of the broader research team, contributes to lab projects and initiatives.Other duties as assigned.