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Regulatory Coordinator Oncology Clinical Research Unit [CRU] Brain TUMOR CLINICAL Research Program [BTC] Position Description, Occupational Summary Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] TEAM Clinical Research Program [BTC.
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Extensive knowledge of clinical research regulatory compliance. The Senior Director monitors and supports teams responsible for study start-up activities, site activation and maintenance, compliance with all regulatory requirements and Federal guidance, subject accrual and management in close coordination with physician investigators, nursing, finance, and regulatory operations.
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Description The Clinical Research Coordinator A is responsible for oversight, execution, and regulatory compliance of human subject research carried out in the Epilepsy Division of the Neurology Department.
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Join us as we continue to grow, the Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines.
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The Postdoctoral Clinical Research Fellows is a 12-month position designed to assist in the research at the Advent Health Research Institute (FHRI) and participates in Industry/National Institute of Health (NIH)/Pharmaceutical and government sponsored and investigator-initiated research that supports the FHRI scientific research plan.
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Responsibilities:- Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Our research programs encompass a broad range of biomedical research activities and areas of study, focusing on various fields such as cardiovascular disease, alcoholism, hematopoietic cancer, behavioral research, aging, and gene therapy.
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The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology company studies.
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Position Summary Clinical Veterinarian The Laboratory Animal Resource Center (LARC) at a prestigious institution is seeking a customer service-oriented individual to join our team as a clinical laboratory animal veterinarian and Assistant Director.
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Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation.
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In this highly visible role, you will partner with a large, global pharmaceutical company and provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure client's products are developed/maintained in compliance with global regulatory requirements and guidances.
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Microscopy, tissue imaging (IHC, fluorescence microscopy), flow cytometryExcellent written and oral communication skills including good presentation skillsStrong business acumen; including knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, research, biostatistics, clinical pharmacology, regulatory, commercial operations, etc.
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This is a non-tenure research track faculty position. - Provide veterinary preventive, clinical, diagnostic, technical, and surgical services, with a focus on USDregulated species, frogs, laboratory mice and rats.
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Job Summary: The Sr. Regulatory & Compliance Specialist is responsible for assuring compliance with all food safety & regulatory matters, also for supporting the Sr. QA Manager in developing, implementing, and enforcing Food Safety Programs for the company (including SQF program), oversees the plant SQF program to ensure certification is maintained.
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Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
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clinical research pharmaceutical company regulatory compliance jobs Company: Abbott
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