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Masters degree preferred preferably in research administration, healthcare administration, business administration, legal or regulatory studies, biomedical, science, or another research-related field.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such as clinical research coordinator experience. The Protocol Project Manager (PPM) will work in the Pediatric Oncology research program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and the Clinical Research Support Office (CRSO), which is a centralized service unit in the HDFCCC offering clinical trial management services.
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Experience conducting high risk biomedical research and/or oncology regulatory research experience preferred. The NCI/NCTN Senior Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation.
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With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers.
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Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; A proven track record in clinical medicine and background in biomedical research is essential.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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BS or MS degree in Software Engineering, Biomedical Engineering, Electical Engineering, Computer Science, Regulatory Affairs or another scientific discipline. Glooko is the Unified Platform for Diabetes Management and provides an FDcleared, HIPAcompliant Web and Mobile (iOS and Android) application for people with diabetes, the clinicians who treat them, and those conducting clinical research on diabetes treatment.
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The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
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Minimum of 12 years of medical affairs or clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned.
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The Director must understand the entire preclinical and early clinical product development pipeline including product optimization, preclinical scale-up, and manufacture and toxicology, regulatory affairs, and early human clinical trials.
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Interface broadly with key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late-stage clinical research.
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Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.
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Provide oversight to CCC, SDMC, and Access Hub staff across the network responsible for fielding questions, including questions in relation to the protocol, training and quality assurance, assays, information systems, reporting, regulatory affairs, subcontracts, and site payments.
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Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application. Plan, conduct, and lead complex clinical study audits (Sponsor, Investigator Sites and Clinical Suppliers) (either remote or on site) in accordance with all applicable regulations, standards, mentorship, and the established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated 28 days ago
clinical research regulatory affairs biomedical jobs in TX, Us
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