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Qualifications REQUIRED QUALIFICATIONS High School diploma Minimum two years' experience in a clinical research, clinical laboratory, or cancer registry environment with regulatory or human research protections.
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Knowledge of research guidelines and regulatory requirements established by such federal and state agencies as the FDA, National Institutes of Health (NIH), Benaroya Research Institute (BRI) at Virginia Mason and database collection.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. TMAC’s direct-hire service, formerly known as TMAC Direct, is an award-winning executive search firm that specializes in permanent placement services for the Pharmaceutical, Biotech, Diagnostics, Device, and Life Science Research industries.
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In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
$111,972 - $174,468 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Is responsible for the overall program activities and administrative operations including strategy, financial, personnel, grants and contracts, regulatory and administrative functions for a broad program comprised of independent research groups within the Translational Science and Therapeutics Division of Fred Hutch.
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The regulatory coordinator is responsible for overseeing the regulatory affairs of the Phase 1 Research Program's clinical trials. It will integrate information from multiple sources and use specialized regulatory knowledge of the governing clinical research policies, to ensure all clinical trials are compliant with applicable federal and institutional regulations.
$5,700 - $6,800 a monthFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Clinical Research Coordinator certification (CCRC) or Research Professionals certification (ACRP or SOCRA) Two to three years of work experience in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review in pharmaceutical, biotechnology, or academic research settings.
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Strong experience in patient centered outcomes research: COA instrument development/psychometric validation, quantitative analysis of CObased clinical study endpoints, regulatory dossier development and submissions.
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With input from PI(s), draft research protocol documents and clinical research informed consent forms. Experience with regulatory affairs in an academic research environment.
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Responsibilities The Regulatory Affairs Associate ensures proper oversight of investigator-initiated clinical research and lab-based studies. IRB, Regulatory and/or Clinical research-related certification preferred (CIP, RAPS, ACRP, SOCRA.
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In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead’s products.
$130,220 - $168,520ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols throughout the research process. Stay abreast of developments in clinical research, therapeutic areas, and regulatory requirements.
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Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc. A minimum of 3 years relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination function required.
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Minimum two to three years' experience in a clinical research or cancer registry environment with regulatory or human research protections. The Clinical Research Coordinator II is primarily responsible for ensuring that all administrative aspects of a study are completed in a timely and compliant manner.
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5+ years’ experience in capital equipment sales into either a clinical or research environments (Hospital / Pathology / LIS / Connectivity/ Digital Pathology / Imaging background preferred.
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clinical research regulatory jobs in Seattle, WA
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