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Animal Models, Animal Models, Apache Continuum, Bioinformatics, Chemistry, Clinical Research, Collaboration, Communication Skills, Data Analysis, Drug Development, Drug Discovery, Due Diligence, Ethics, Flexibility, Influencing Skills, Job Description, Laboratory, Lifesciences, Line Of Business, Medical Research, Patient Care, Pharmaceutics, Problem Solving, Project Management, Regulatory Compliance {+ 4 more.
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These responsibilities relate to the UNC / LCCC Clinical Research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.
$40,945 - $53,341 a yearPart-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Participates and ensures preparedness in both internal and external audits for data quality, regulatory compliance, patient safety issues related to clinical trial participation.
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Independently authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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The Preclinical Safety (PCS) organization within Translational Medicine provides world class preclinical safety profiling and assessment for efficient drug discovery, development, and commercialization with innovative regulatory compliance.
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Emphasizing and embedding quality in the execution of clinical trials, post market vigilance and post market studies, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs.
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Manage and oversee the implementation of clinical trials in adherence to GCP and ICH guidelines, including tasks such as participant recruitment, obtaining informed consent, continuous protocol monitoring for compliance and patient safety, reviewing source documents, data entry, and sponsor monitoring.
$45 - $47 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities.
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A minimum of 2 years of on-site monitoring experience is required, however monitoring experience may be waived if relevant Novo Nordisk experience is demonstrated in GCP-related clinical research.
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Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials and improvement/innovation projects for NACD and Novo Nordisk (e.g., clinical trial site staff, clinical research vendors.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities.
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As the Clinical Research Monitor on the Aortic team, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
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With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
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Additional Information: Maintaining regulatory compliance in clinical trials is essential for safeguarding patient safety, upholding ethical standards, ensuring data integrity, and facilitating the development and approval of new medical treatments and technologies.
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As the Senior Clinical Research Monitor, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
$71Full-timeExpandApply NowActive JobUpdated 3 months ago
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