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Certification by American Society of Clinical Pathologists (ASCP) or National Credentialing Agency (NCA) or equivalent agency as a Medical Technologist, Clinical Laboratory Scientist, Medical Laboratory Technician, or specialty certification is preferred.
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The Clinical Research Coordinator (CRC) at the Alzheimer's and Dementia Research Program for Asian Americans and Other Minority Groups , led by Dr. Clara Li, at Icahn School of Medicine at Mount Sinai, assists clinical studies sponsored by the NIH and industry.
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Compliance and Education·Performs preparatory regulatory compliance audits of IRB-approved clinical research protocols at MGB institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines (GCP), as well as with MGB clinical research policies.
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Strong acumen and demonstrated ability in GLP/GCP auditing , FDA and EMEA regulations inclusive of direct experience with Pharmacovigilance and System Development Life Cycle activities. Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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Assesses and evaluates potential organ and tissue donors working collaboratively with the Donor Services Center staff and the Family Service Coordinators, communicates with donor families, directs clinical management of the organ donor, and coordinates the organ and tissue recovery process with medical teams to surgically recovery and transport organs and tissues.
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Conducts all aspects of the donation process in compliance with established federal and state laws, OCME, AOPO and AATB standards, UNOS and FDA guidelines, CDC recommendations, AORN guidelines for aseptic technique and Infinite Legacy policies.
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Regulatory compliance must be enforced throughout the Clinical Trials Department to ensure compliance with FDA regulations, Good Clinical Research Practice Guidelines as outlined by the World Health Organization, and requirements of the National Institute of Health.
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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines.
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Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU and Lurie Institutional Review Boards (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
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As a member of The US Oncology Network , one of the nation's largest community-based cancer treatment and research networks, Compass Oncology participates in leading-edge clinical trials through US Oncology research, which has helped develop 89 FDA approved cancer therapies.
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With minimal guidance, implement clinical trials and research projects that meet CommonSpirit Health Research Institute (CSHRI) and facility/clinic objectives, and ensure compliance with protocol and sponsor requirements and all aspects of U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, as well as CSHRI requirements.
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Bachelor's degree in medical technology, clinical laboratory, chemical, physical or biological OR Associate degree in chemical, physical or biological science or medical laboratory or equivalent education and training PLUS one year laboratory experience.
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Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator II (CRC-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors.
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As part of our continued efforts to maintain a safe workplace for employees and clients, and in compliance with the City of New York COVID-19 Safety Requirement Mandate, Breaking Ground strongly recommends all employees, interns, volunteers, and subcontractors to receive an FDA authorized and/or approved COVID-19 vaccination and provide a one-time verification of immunization as a condition of employment.
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Actively engages with industry related agencies and professional membership organizations including CMS, FDA, UNOS, AOPO, AATB, EBAA, ASHI, CLIA, and ISODP. Provides interpretation and guidance of regulations and standards for consideration in the formulation of business strategies related to organ, tissue, ocular, HLA and Clinical Laboratory operations and organizational regulatory compliance.
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