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Support advisory boards or roundtables for clinical trials phase IV in asthma and COPD and gain strategic insights for medical, scientific, and development strategy. Maintain strong knowledge in asthma and COPD to optimize clinical study protocols development and execution.
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Support the development of biomarker related aspects of the trial design, study protocols, lab manuals, clinical study reports, investigator brochures and regulatory documents. Six or more years of experience in biomarker development and implementation in oncology clinical trials is required.
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Leverage real-world data for patient matching and improving Diversity, Equity, and Inclusion (DE&I) in clinical trials. Protocol Design Optimization- evaluating and proposing options for eligibility optimization, hybrid trials, and decentralized clinical trials models.
$142,000 - $244,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Core functions include: Set-up, organize, and maintain clinical study documentation ( Trial Master File documents, clinical study site documents, email correspondence, training materials, etc.
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Assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.
$96,000 - $134,667 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms.
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Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality oncology clinical trials including protocol development, medical review, oversight of safety, study conduct, and data quality.
$131,000 - $225,400 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Assists investigator with consent process assuring patients understand clinical trials. Knowledge of clinical trials and the regulation (local, state, and federal) of such.
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Represent QA in study team(s) where relevant and participate as appropriate to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
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Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
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Assist in the conduct of clinical trials as specified by the study protocol under the supervision of designated Principal Investigator and departmental management. Record observatio Research Coordinator, Clinical Research, Part Time, Department Manager, Clinical, Coordinator, Healthcare.
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Performs coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding with the clinical study manager and Medical Monitor.
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Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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The Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and the associated clinical trials.
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Biostatistician (2 x openings) in Somerset, NJ : Write/review clinical research protocol, SAP and study report for clinical trials projects; develop and validate statistical models and SAS programs for analysis, management and reporting of clinical trials data, generate and validate safety and efficacy TLGs, analysis datasets (SDTM, ADaM) and clinical trial reports.
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clinical trials study jobs in Piscataway, NJ
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