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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 Clinical Research Coordinator (CRC) is an integral and essential member of the ACC CRU Melanoma Research Team. We are looking for an enthusiastic, professional and committed team member to work closely with our clinical research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator.
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Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinators to join our Study Start-up team. We have openings for clinical research coordinators to best match your experience level.
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3-5 years relevant experience in at least one of the following fields: Outcomes Research, HE, Clinical Research, Epidemiology, Health Policy. Provide oversight and strategic and scientific input for HEOR projects, data interpretation, protocol development, regulatory documents, scientific publications, and independent research proposals for assigned products.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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DescriptionJanssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
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Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators.
RemoteExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Brain Modulation Lab is involved with several major NIH and industry-sponsored clinical trials and the Project Manager will support multiple active protocols, serve in the capacity of lead Clinical Research Coordinator of trial teams, maintain regulatory documentation, Standard Operating Procedures, and train staff members to ensure compliance.
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Under the direction of the Hospital Coding Manager or Supervisor, and exercising independent judgment within the scope of the job, the Hospital Inpatient Coder II assigns applicable ICD-10 Codes, Present on Admission (POA), Hospital Acquired Condition (HAC), and Patient Safety Indicators (PSI) using current industry standards, the Official Coding Guidelines, Coding Clinic, UHDDS and regulatory requirements.
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Medical and Scientific Affairs serves a critical internal leadership and customer-facing support role, including pre- and post-market partnership to functions such as product management, sales and marketing, R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Innovation, Strategy, Pharmaceutical Partnerships (Companion Diagnostics), and Technical Support.
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Collaboratively liaising with the Associate Vice President of Behavioral Health Services (AVP BHS), Senior Director of Supportive Reentry Services, the Senior Director of Clinical Services, other direct reports, and Quality Assurance Administrator to ensure operational excellence, streamline processes, and guarantee that services align with regulatory, contractual, and revenue cycle standards.
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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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The Clinical Research Coordinator is also responsible for keeping all data and source documentations, adverse event reporting, and IRB regulatory files. The primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials in cardiovascular and chronic kidney diseases.
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In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material.
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Janssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
$131,000 - $225,400 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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