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Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
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Ensures that departments/areas comply with or exceed all regulatory requirements including, but not limited to JCAHO, CDPH, CAP, OSHA, FDA.Manages the cancer DSL Network quality staff across all outpatient and inpatient departments, including BMT/CTF, radiation oncology, infusion services, cancer clinics, integrated clinical research, and Surgical Oncology; works with the operational and clinical research leaders to ensure all quality goals are met.
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Job Responsibilities Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
$165,580 - $214,280ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We are looking for an expert Quality Assurance Professional with experience advising research and development teams in Good Clinical Laboratory Practices (GCLP) quality strategy within a pharmaceutical organization.
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Collaborate with partners in Process Development, Regulatory, and Clinical groups to fulfill company objectives (Tech Transfer, IND filings, IP) Design, execute, and analyze preclinical research studies focused on engineering stem cells, and spanning molecular biology and cell biology.
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The NCI-Designation recognizes the scientific leadership, resources, and the depth and breadth of the research in basic, clinical and population science. At the UCSF Helen Diller Family Comprehensive Cancer Center we are truly pioneering care and leaders in all areas of cancer clinical care and research.
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Accountable for providing scientific input and biomarker expertise across all aspects of early development plans and collaborations (such clinical protocols, sample collection tables, sample collection instructions and logistics, scopes of work, data transfer agreements, validation reports, study reports, central lab logistics, posters, publications, investigator brochures, INDs, regulatory documents, etc.
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This person will work closely with other teams including biologics discovery, toxicology, clinical pharmacology, pharmaceutical sciences, and regulatory to ensure optimal leads and successful clinical evaluations.
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Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
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We seek a Clinical Research Coordinator 2 – Radiology to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education, and outreach.
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The Clinical Research Associate will be responsible for practicing a standardized cognitive behavioral intervention as part of a federally-funded study of nonpharmacological treatment for headache attributable to mild traumatic brain injury.
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The Director, Clinical Operations (TMF, CTMS) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions.
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Partners with all functional areas (translational research, CMC, regulatory affairs, clinical development, clinical operations, and pharmacovigilance) to build and maintain integrated project timelines, track progress, resolve conflicts, and communicate current project status.
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Advice on legal issues throughout the medical device lifecycle related to clinical research, market access and reimbursement, product launches, commercialization, advertising and promotion, social media, patient access and financial assistance programs.
$135,400 - $182,800 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to: Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.
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clinical research regulatory jobs in San Carlos, CA
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