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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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Runs portions of clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation.
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Veeva Vault, our cloud-based content management, and collaboration solution are used by our customers to manage content-centric processes across key departments within a life sciences company, including clinical trials, quality management, manufacturing, regulatory, sales, and marketing.
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Our RESET TM clinical trials with CAB201 (investigational CD19-CAR T cell therapy) in lupus and myositis are now recruiting. The Associate Director, Clinical Data Management will manage all data management (DM) activities from start-up through long term follow up and archival, overseeing high quality databases for analysis and potential regulatory submissions.
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Lead the management and oversight of regulatory activities relating to clinical trials including but not limited to clinical trial applications. Establish regulatory strategies and process by collaborating and coordinating with relevant development and CMC team members.
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Regulatory, QA & Clinical Trials and other emerging technologies, etc., Areas of business growth include Biometrics (Clinical SAS, Clinical Data Management, Biostatistics, Pharmacovigilance, etc.
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With the support of the study team, the research nurse will carry out state of the art clinical trials and other research studies, including consenting, screening, and enrolling eligible subjects, managing the treatment of patients throughout their participation in the study including education about any adverse effects they might experience, provide oversight and coordination of research testing and follow-up.
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Coordinate the day-to-day management of clinical research trials, including IRB, and NIH regulatory documentation. Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.
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Kn wledge 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.
$148,000 - $194,250 a yearFull-timeRemoteExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Regulatory Coordinator will work under the supervision of the Sr. Manager, CRORA to prepare, submit, and maintain regulatory documents for investigators in the LKSOM. The Regulatory Coordinator will prepare submissions to the Temple IRB and external IRBs. In addition, the Regulatory Coordinator will create and manage study binders in the Florence electronic Trial Master File.
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Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Understanding of regulatory requirements, principles of GCP, FDA regulations, and biomedical research ethics. Industry research experience and industry-sponsored clinical trials are preferred.
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The Clinical Research Coordinator will support such researchers providing the required elements necessary to retain regulatory and ethical compliance with all aspects of the clinical trial process.
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Study Coordinator, Clinical Manager, Clinical Research Associate, Clinical Research Associate, Clinical Research Regulatory. Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.
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This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
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trials regulatory jobs in Harrisburg, PA
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