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Under the guidance of regulatory personnel within the Clinical Trials department, the Oncology Research Coordinator will collaborate with physicians, nurses and other key personnel to ensure compliance with the regulations of study sponsors, the Halifax Oversight Committee, and Institutional Review Boards (IRB.
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The Clinical Research Coordinator B (Regulatory Coordinator) will play a critical role in ensuring research studies comply with relevant regulations and guidelines and will recruit and screen patients for clinical trials as needed.
$43,919 - $56,349 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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The Clinical Research Associate is responsible for managing assigned clinical research trials and ensuring the trials are on schedule and in compliance with all regulatory requirements.
$111,170 - $185,284 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The successful applicant will be part of the University of Wisconsin-Madison's Program for Advance Cell Therapy (PACT) multidisciplinary team led by Associate Dean Jacques Galipeau and focused on deployment of cell and gene therapy first-in-human and early phase clinical trials in partnership with UW Health clinical translational research professionals.
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Assist the Division Counsel for Research in the review of and advice on research enterprise concerns, including effort reporting, grant accounting, clinical trials billing, and the application of the fraud, waste and abuse laws and regulations to sponsor-supplied equipment, medication and treatment supplies.
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Apply locations Radnor, PA USMO Remote USCT Remote USOK Remote USMN Remote time type Full time posted on Posted Yesterday job requisition id R-154388 Avantor’s Legal Department is seeking a Senior Counsel, Litigation and Investigations (Commercial and Regulatory) to support client groups within Avantor’s enterprise, reporting to Vice President, Deputy General Counsel, Litigation.
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As a key stakeholder, the Director represents the investigator/research team when working with internal regulatory groups such as the IRB, OCR, Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), Data Safety and Monitoring Committee (DSMC), and DOCM, as well as external entities including pharmaceutical companies, contract research organizations, the FDA, and the NCI's National Clinical Trials Network (NCTN) groups.
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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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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
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This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate.
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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.
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Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
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This role is an opportunity for an experienced Clinical Operations Professional with technical expertise supporting Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulatory requirements.
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The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology company studies.
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