Human Subject Research Coordinator II at University of Rochester in Rochester, NY

Job description

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: 400093 Neurology-Epilepsy Unit 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 Epilepsy Human Subjects Research Coordinator II will provide essential research support and study coordination for several studies in the Epilepsy Division in the Department of Neurology. The research projects in the group include both investigator initiated studies, and pharmaceutical company funded multi-center clinical research studies in children and adults. The Study Coordinator II will have considerable latitude for independent judgment and coordinates 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, assisting all faculty as well as residents/fellows with IRB submissions. ESSENTIAL FUNCTIONS Oversees and coordinates human subject research activities including pre-screening potential study participants for multiple research studies. Must be able to learn multiple study protocols to become well versed in study requirements. HSRC will recruit participants, schedule, and conduct subject visits for research studies in accordance with study protocol. Perform activities including but not limited to participant consent, data collection, and assessments as required per protocol. Resolves questions and concerns received from study subjects or sponsor, triaging to the Principal Investigator as necessary. Conducts study visits; coordinating all tasks including participant assessments, medication compliance, clinical tasks (obtaining vital signs, ECG) as well as tasks assigned to nursing staff and Principal Investigator. Complete post-visit tasks, such as shipping specimens, logging in OnCore and Advarra Payment systems and data entry into the Electronic Data Capture (EDC). Develop and monitor visit calendar for all participant visits over the life of the study. Maintain subject binder, ensuring completeness for study integrity Manages study start up activities, including obtaining quotes from ancillary departments (imaging, laboratory, Clinical Research Center) and modifying consent forms per UR guidelines to ready for RSRB (UR’s IRB)/ Institutional Review Board (IRB) submission. Participates in the planning, development and implementation of study design, protocols, consent forms, processes and policies. Works with Research Administration team providing expertise related to time studies and budget feasibility for study procedures, overall complexity and effort required for completing studies Develops and/or manages databases and source documents/case report forms (CRF’s) for research studies, ensuring CRF’s are aligned with protocol requirements. Completes data entry in a timely manner and review database(s) for incomplete items or queries Serves as the liaison between cross-functional research team, additional research sites, study sponsors and IRB to facilitate communication and resolve issues. Represent URMC and Principal Investigato