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The MEL conducts critical activities that support advancing science, educating on evolving clinical practices, transforming science into patient care, and facilitating the development of new research collaborations (including Investigator Initiated Trials and Real-World Evidence.
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Assist Clinical Scientist, Study Responsible Scientist (SRS), &/or Study Responsible Physician (SRP) in various clinical research assigned Immunology Development clinical trials.
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Coordinate patient care activities and participate in the conduct of studies for patients enrolled in clinical trials for multiple services including medicine and radiation oncology. Clinical Trials Nurse- Monmouth, New Jersey, (Ambulatory Outpatient site.
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As a Senior Clinical Manufacturing Associate, you will be part of a team responsible for the cGMP manufacture of viral vector therapies for use in clinical trials. Subject matter expert in clinical manufacturing including cell culture techniques and principles, bioreactor operations, depth filtration, OR tangential flow filtration, chromatography, and single use techniques and principles and aseptic techniques.
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Develop and implement or update policies, SOPs, guidelines, and associated internal communications related to non-promotional, medical/clinical programs, including congress activity, educational programs, use of publications and reprints, commercial medical interactions, advisory boards, ad hoc consulting, IITs, clinical trials, Mock FDA meetings, etc.
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PhD (9+ years experience) or MS (11+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
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The Oncology Nurse Research Coordinator will work closely with the members of the clinical research team to develop highly effective tools for close monitoring and reporting of trials and coordinate the timely study activation and submission of protocol amendments.
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As the Contractor, Senior Clinical Data Manager, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.
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Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
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You can proactively assess information and investigate impact on clinical trials. Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance.
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The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
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This CRS will focus mostly on pediatric regulatory documents and the execution of pediatric clinical trials. Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL.
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Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.g. review.
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Educate those patients and their families regarding clinical trials in general and the specifics of the proposed clinical trial. Facilitate accrual of appropriate patients to clinical trials.
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Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.
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clinical trials jobs in Morrisville, PA
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