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Field work and nationwide travel, including travel to Amtrak regional offices nationwide, accident sites as necessary and attending regulatory agency investigations, meetings and hearings, as well as litigation-related mediations, settlement conferences, trials and court appearances as necessary.
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Reporting to the Clinical Research Manager of Cancer Cell Therapy (CCT), the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to to manage data, enroll and follow patients on trial, and assist with regulatory and financial requirements of the trials.
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Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
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Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
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Serves as Study Coordinator for pharmaceutical trials. Supports regulatory staff submission of study protocols and amendments, consent forms, and recruiting materials to the Institutional Review Board and department for approval with oversight from supervisor.
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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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2-3 years in a healthcare specialty required; experience in apheresis, cell therapy/ stem cell transplantation, bone marrow transplant, hem/onc, laboratory medicine, and/or regulatory compliance/quality assurance preferred.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Serve as a leader supporting the overall CPP and/or translational medicine organizational objectives Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization; Publish in peer reviewed journals.
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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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Clinical pharmacokinetics, clinical pharmacology, clinical trials, clinical drug development, scientific leadership, associate director, drug discovery, pharmacodynamics, bioanalysis. Strong knowledge of pharmacokinetics and pharmacodynamics, with experience in drug development processes and regulatory interactions.
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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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The Regulatory Affairs Specialist is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site trials.
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The individual will be responsible for assisting the PIs and other faculty in conducting National Institute of Health (NIH), industry sponsored clinical trials, and/or investigator-initiated trials.
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Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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