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The Associate Counsel will focus on the efficient and effective management of all department’s business contracts and processes to ensure best industry standards are adhered to while protecting the legal interests of the institution and its affiliates (e.g., Lovelace Biomedical Research Institute, Westchester Medical Center, Touro University IRB, etc.
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B) the Health Sciences Institutional Review Board (HSIRB) and the Institutional Review Board for the Protection of Human Subjects #1 (IRB #1) As directed maintains the OSP homepage of resource and policy materials for researchers on Touro College’s website; serves as the OSP liaison with Touro’s webmaster and IT department.
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Job Responsibilities:Serve as the key leader for human subjects research conducted at the Winifred Masterson Burke Rehabilitation HospitalServe as lead contact among investigators, department administrators, IRB, and (Einstein/Montefiore) units (Conflict of Interest Office, Office of Biotechnology and Business Development, etc.
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Authors, reviews and finalizes the medical and scientific portions of protocol synopsis and clinical study protocols and amendments; Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
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This position is based at the Center for Autism and the Developing Brain (CADB) located at the Westchester Division in White Plains, NY. Primary responsibilities include behavioral coding, subject recruitment, testing participants with standardized assessments, as well as play-based assessments, managing and analyzing datasets, preparing and maintaining IRB protocols, and running ERP/EEG tasks if needed.
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Familiarity with the life cycle of federally funded programs, including issues related to federal procurement contracts and federal grants, as well as dispute resolution processes. Must be available for up to 25% domestic travel to Lovelace’s headquarters in Albuquerque, New Mexico and Touro University’s other research hubs.
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Authors, reviews, and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions. Evolving Genetic Medicines modalities include RNA Interference (RNAi), CRISPR gene editing, AAV gene delivery, and others.
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Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety. Takes lead on collaborations with discovery scientists and translational colleagues to understand current and emerging genetic targets across a variety of therapeutic areas and disease states including but not limited to cardiovascular and metabolism, rare diseases, and others; provide input on potential disease areas/indications; and craft clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs.
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