Human Subjects Research Coordinator II

The University of Rochester is seeking a Neuromuscular Disease Study Coordinator II. This is a full‑time, regular worker role at the Department of Neurology with scheduled weekly hours of 40, located at 220 Hutchison Rd, Rochester, New York, 14620. The position offers a compensation range of $25.14–$35.24 per hour.

• Manage projects primarily in Facioscapulohumeral Muscular Dystrophy and other neuromuscular diseases, including observational studies, clinical trials, and multi‑center research involving adult and pediatric subjects.
• Provide independent judgment and coordinate all aspects of assigned human subject research studies, assisting Principal Investigator(s) and serving as an integral part of the research team.
• Mentor Human Subject Research Coordinator I(s) and supervise students as assigned.
• Recruit, consent, enroll, and retain study subjects across the NMD portfolio of studies.
• Develop, implement, and evaluate subject recruitment and retention strategies; create and modify patient recruitment material; manage and update registries used for subject recruitment.
• Coordinate, schedule, and conduct research study visits per protocol; perform study‑related procedures outlined in the protocol; ensure proper training for protocol procedures and study drug/materials handling.
• Resolve subject questions, triage to Principal Investigator when needed; ensure clinical care resources are available to support human subject studies.
• Input, regularly update, and review patient information in databases; promptly resolve data queries to maintain accuracy.
• Mentor and train NMD Study Coordinators (HSRC I) and provide backup support across the team.
• Direct and interpret study protocols, procedures, documentation, and study materials; ensure compliance, follow up, and communicate as needed.
• Stay current with study‑specific training, sponsor/institutional policies, SOPs, and guidelines.
• Troubleshoot and resolve operational issues related to studies.
• Develop, modify, and maintain regulatory documents for multiple research studies; manage IRB submissions (study applications, amendments, continuing reviews); maintain regulatory files.
• Ensure consistency and standardization of protocol activities across multiple sites; monitor compliance with regulatory and institutional policies, taking corrective action when identified.
• Train on federal, state, sponsor, and institutional regulations, policies, and practices related to human subject research.
• Liaise between cross‑functional research team, additional research sites, research administration, study sponsors, and IRB to facilitate communication and collaboration.
• Work with research administration on pre‑award and study start‑up documents, providing expertise on time studies, budget feasibility for study procedures, and overall complexity.
• Review study progress and update OnCore or other workbooks on enrollment, visits, and completed procedures to ensure accurate payment and expense monitoring.
• Represent the University and Principal Investigator at study meetings; prepare and attend sponsor monitor meetings.
• Develop, manage, and oversee databases for research studies; ensure timely data entry and data integrity; export research data and collaborate with Data Office staff for analysis, presentations, abstracts, and publications.
• Attend training sessions and educational opportunities related to clinical research; keep current with Good Clinical Practice guidelines, federal and state policies, laws, institutional certifications, industry standards, and trends in relevant therapeutic areas.
• Participate in study team meetings and provide updates on project status and regulatory changes as needed.
• Perform other duties as assigned.

• Bachelor's degree and 2 years of experience in human subject research coordination, or an equivalent combination of education and experience.
• Experience as a Phlebotomist preferred.

• Proficiency with word processing and data analysis software.
• Experience as Human Subject Research Coordinator I preferred.
• Proficiency with Excel spreadsheets and electronic databases preferred.

• SOCRA – Certification in Clinical Research upon hire (preferred).
• ACRP – Association of Clinical Research Professionals upon hire (preferred).

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture. We are an equal opportunity employer and prohibit discrimination on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law.