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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Education, Knowledge, Skills and Abilities Preferred: Education on human subject research and GCP. Licenses and Certifications Preferred:SOCRCertified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC.
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We invested in new offices, sector teams and practice groups including higher education; foundations; investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and creative services.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Under the direction of the Office of Oncology Research Regulatory Affairs and Compliance, the Regulatory Specialist I performs administrative and coordinative work directed toward the design, implementation, evaluation and review of assigned Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) clinical trials by working closely with Principal Investigators and other clinical trial staff members.
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Regulatory Coordinator Oncology Clinical Research Unit [CRU] Brain TUMOR CLINICAL Research Program [BTC] 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] TEAM Clinical Research Program [BTC.
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In addition to the responsibilities above, the Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting.
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A day in the life of a Lead Clinical Research Nurse at Hackensack Meridian Health may include: Works together with and oversees all assigned Clinical Research Nurses Interacts with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
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Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Responsibilities:- Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Our research programs encompass a broad range of biomedical research activities and areas of study, focusing on various fields such as cardiovascular disease, alcoholism, hematopoietic cancer, behavioral research, aging, and gene therapy.
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Position Summary Clinical Veterinarian The Laboratory Animal Resource Center (LARC) at a prestigious institution is seeking a customer service-oriented individual to join our team as a clinical laboratory animal veterinarian and Assistant Director.
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However, qualified individuals with documented past academic rank advancement may qualify for the associate scientist faculty rank. This is a non-tenure research track faculty position.
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Provide veterinary preventive, clinical, diagnostic, technical, and surgical services, with a focus on USDregulated species, frogs, laboratory mice and rats. - Participate in training programs for LARC employees, research personnel, veterinary residents, veterinary students, and others.
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clinical research regulatory affairs associate jobs Company: Aa2it in TX, Us
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