Human Subject Replacement

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. **Job Location (Full Address):** 220 Hutchison Rd, Rochester, New York, United States of America, 14620 **Opening:** Worker Subtype: Regular Time Type: Full time Scheduled Weekly Hours: 40 Department: 400094 Neurology - NMD M & D Work Shift: UR - Day (United States of America) Range: UR URG 108 H Compensation Range: $25.14 - $35.24 *The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.* **Responsibilities:** The Neuromuscular Disease Study Coordinator II will manage projects primarily in Facioscapulohumeral Muscular Dystrophy, with the ability to work on projects in other neuromuscular diseases. The research projects in the group include observational studies, clinical trials, and multi-center clinical research studies in both adult and pediatric subjects. The Study Coordinator II will have considerable latitude for independent judgment and will coordinate all aspects of assigned human subject research studies. This role provides assistance to the Principal Investigator(s) and works as an integral part of the research team. This role mentors Human Subject Research Coordinator I(s) and supervises students as assigned. **ESSENTIAL FUNCTIONS** - Uses independent clinical judgment to recruit, consent, enroll and retain study subjects across the NMD portfolio of human subjects’ studies. Develops, implements, and evaluates subject recruitment and retention strategies. Creates and modifies patient recruitment material as necessary. Manages and updates registries used for subject recruitment. - Coordinates, schedules, and conducts research study visits according to the protocol to support successful achievement of milestones, specific aims, and study objectives. Performs study-related procedures as outlined in the protocol. Training will be provided to implement protocol’s procedures. Coordinates and documents dispensing and returning of study drugs/materials, as applicable. Resolves study subject questions and concerns, triaging to Principal Investigator, as necessary. Ensures patient clinical care resources are available to support conduct of human subject studies in accordance with protocol. Inputs/regularly updates and reviews all patient information in the patient databases to ensure the most accurate databases possible, including resolving data queries timely. - Mentors and trains NMD Study Coordinators (HSRC I) on activities related to conducting human subject research and provides back-up support across the team as needed. Directs, understands, implements, and provides training on most recent study protocol (e.g., amended protocol), procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, following up and communicating as needed. Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines. Troubleshoots and resolves operational issues related to studies. - Develops, modifies and maintains regulatory requirements for multiple research studies. Manages IRB submissions to include study applications, amendments and continuing reviews. Creates, modifies, organizes, and maintains study documentation for the regulatory file. Ensures consistency and standardiza…