Human Subject Research Specialist II

Job Location: 220 Hutchison Rd, Rochester, New York, United States of America, 14620 Opening: Regular Time Type: Full time Scheduled Weekly Hours: 40

Department: Neurology - NMD M & DWork Shift: UR - Day (United States of America)

Responsibilities: The Study Coordinator will coordinate clinical research projects involving patients with muscular dystrophy, in specific, myotonic dystrophy. These projects include clinical trials evaluating genetic therapies targeting the root cause of the disease and observational studies, e.g., leveraging a remote research platform developed by the DM research team. The study coordinator will assist in enhancing and expanding the remote research platform. The Study Coordinator II will work as an integral part of the research team, assisting the principal investigator, communicating with study participants, and the broader DM community. This role mentors Human Subject Research Coordinator I(s) and supervises students as assigned.

Essential Functions: Coordinates, schedules, and conducts research study visits in accordance with the protocol to support the successful achievement of milestones, specific aims, and study objectives. Performs study-related procedures as outlined in the protocol. Training will be provided where necessary to implement the protocol's procedures. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator as necessary. Coordinates and schedules appointments and works with multidisciplinary teams. Performs testing, including timed mobility tests and questionnaire administration and creates shipments of biological materials. Assists with study start-up activities including budget development, ancillary approvals, and the creation of study materials. Monitors changes in patients' health and performs safety reporting and follow-up. Maintains patient charts and facilitates study monitoring with sponsors and contract research organizations. Assist in remote research platform management. This includes monitoring equipment sent to and from study participants, cleaning and preparing equipment for shipment, and facilitating remote patient blood sample collection. Uses independent clinical judgement to recruit, consent, enroll, and retain study subjects across human subjects' studies. Develops, implements, and evaluates subject recruitment and retention strategies. Creates and modifies patient recruitment material as necessary. Leads patient recruitment initiatives and community outreach initiatives, such as participation in patient conferences. Manages and updates registries used for subject recruitment. Ensures adherence to regulatory requirements for research studies. Manages IRB submissions to include study applications, amendments and continuing reviews. Creates, modifies, organizes, and maintains study documentation for the regulatory file. Responsible for monitoring compliance with all regulatory and institutional policies, and takes corrective action on issues identified. Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research. 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 updates to the study protocol, procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance by monitoring progress with training completion and implementation. 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 and/or manages databases for research studies. Ensures data is entered in a timely manner and database(s) is up-to-date. Exports research data used for analysis and preparation of presentations, abstracts, and publications. Develops, implements, and monitors systems and methods to ensure data integrity. Assist in chart abstraction for the maintenance of patient databases. Demonstrates accountability for continuous learning related to clinical research. Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas. Participates in weekly study team meetings and provides updates on project status and changes in regulatory requirements as needed. Other duties as assigned Minimum Education & Experience Bachelor's degree and 2 years of experience in human subject research coordination required Or equivalent combination of education and experience If applicable, department specific experience required Experience as a Phlebotomist preferred Experience as Human Subject Research Coordinator I preferred

Knowledge, Skills and Abilities: Word processing and data analysis software required Expertise with REDCap preferred

Licenses and Certifications: SOCRA - Certification In Clinical Research upon hire preferred Association of Clinical Research Professionals (ACRP) upon hire preferred 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.