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Directly involved with study start-up, implementation, conduct, and close-outs. Completes applications and obtains appropriate approvals from various groups for all necessary study start-up functions.
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Work with the start-up team, CTMS and UW Clinical Trials Office (CTO) to review billing calendars, Medicare Coverage Analysis (MCA), and financial entries and bill routing.
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Kelly Science & Clinical® is working with a growing clinical research network based out of Brooklyn, New York with an immediate need for a Clinical Research Start Up Manager for their clinical trials.
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The Office of Clinical Trials Activation (OCTA) provides business support to investigators and study teams initiating and conducting clinical trials. The UCSF Office of Clinical Trials Activation has a dedicated team of Clinical Trials Activation Analysts, who are responsible for developing and negotiating budgets for a defined group of faculty, and for performing coverage analysis to determine where study costs should be charged.
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Function as a Clinical Data Manager (CDM) to coordinate the day-to-day support of CDM results from study start-up through to database lock to receipt of final study outputs for clinical studies outsourced to contract research organizations.
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The primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials related to maternal health and diabetes.
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Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.
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Regulatory Coordinator Oncology Clinical Research Unit [CRU] Brain TUMOR CLINICAL Research Program [BTC] Position Description, Occupational Summary Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] TEAM Clinical Research Program [BTC.
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Reviews study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs. In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
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Extensive experience in all facets of study start-up/activation, on-going management of multiple protocols, study close-out, and regulatory submission. The Assistant Director of Clinical Data Management further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinating initiatives that identify, prevent, and appropriately mitigate multisite trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university's broader compliance strategy and framework.
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The Clinical Research Supervisor reports to the Research Administrator, Clinical Trials Manager, Research Vice Chairs and works directly with Principal Investigators within the Department of Obstetrics, Gynecology and Women's Health on the execution of reproductive health research studies, focusing on protocol development and coordination, supervising research/study assistants, and data cleaning and monitoring.
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Working closely with Clinical Development R&D functions, enhance analytic capabilities to ensure the right questions are being asked and data is being leveraged to drive study feasibility deliverables and provide data driven recommendations to accelerate our clinical trials in study design and study start up.
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The Clinical Supervisor manages research project activities ensuring the quality and integrity of data collection, and trains, manages, and supports student staff and interns, reviewing work products to ensure study protocol is followed as written and approved by the institution’s IRB. This position will assist with the supervision of research coordinators.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities. Clinical Trial Initiation Manager will deliver high quality and timely global study start-up.
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clinical trials study start up jobs Title: research Company: Medix
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