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The Clinical Research Quality & Regulatory Specialist plays an integral role in the data integrity and regulatory compliance of pharmacy services related clinical research.
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2+ years' experience in research compliance or research administration in an academic or clinical setting. The ORSC educates and supports the University research community with regulatory guidance concerning human subjects research (Institutional Review Board), animal research (Institutional Animal Care and Use Committee), use of biohazardous agents and use of recombinant or synthetic nucleic acids (Institutional Biosafety Committee), and financial conflict of interest in research (FCOI.
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The Program Manager, Clinical Regulatory Compliance & Accreditation works directly with staff, management, and senior leadership to coordinate and perform day-to-day activities related to regulatory compliance across all Dana-Farber sites.
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Regulatory Coordinator Oncology Clinical Research Unit [CRU] GENITOURINARY Clinical Research Program [GU] 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] Genitourinary Clinical Research Program [TNA.
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Job DescriptionThe Clinical Research Coordinator B/C will assist in oversight, execution, and regulatory compliance of human subject research for clinical research projects exploring investigational treatments and diagnostic tools relating to the care of patients with Epilepsy.
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Based out of the Chicago, IL area, the Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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Based out of New York, NY area, The Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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Based out of the San Antonio, TX area, The Travel Clinical Research Coordinator Based primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling andclosely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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Based out of the Cleveland, OH area, The Travel Clinical Research Coordinator Based primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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The Assistant Director of Clinical Data Management further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinating initiatives that identify, prevent, and appropriately mitigate multisite trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university's broader compliance strategy and framework.
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Consult with the Practice Manager to ensure regulatory and quality compliance, including controlled substance management, radiation safety, charging consistency, equipment maintenance, clinical essentials and other practice priorities.
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Key ResponsibilitiesIn collaboration with the Nurse Director, develops department goals, objectives and ensures compliance with hospital policy and procedure, clinical practice, guidelines, and regulatory and accreditation standards.
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Maintains and submits accurate data for hospital-based statistics and regulatory agencies such as UNOS/UNET, CMS, and Medicaid in order to ensure proper department financial management, compliance with all governmental reporting requirements, and proper quality outcomes monitoring.
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QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US.
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The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more.
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