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Perform end-to-end clinical data management activities during study start up, study conduct and study close out according to regulatory requirements and SOPs. Review study protocol; develop and program study case report forms with the study team for online cloud-based implementation.
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CommunicationIndependently/collaboratively performs responsibilities of Level I.Collaborate closely with study coordinator on patient updates and clinical issues to ensure prompt, accurate reporting to sponsor or other entities is handled within protocol/ regulatory guidelines.
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Maintains records in accordance with various regulatory agencies and enters patient and study information into the radiology information system, and documents billing codes of procedures performed to ensure accurate patient charges.
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A Juris Doctorate (JD), Master of Laws (LLM), or Master's degree in Accounting or Taxation field of study will be considered in lieu of a Bachelor Degree in Accounting. Due diligence e.g. interpreting complex legislative and regulatory actions relating to corporate and partnership transactions, assisting clients with regulatory and legislative initiatives, and preparing for client review submission requests for private letter rulings and technical advice from the IRS; and.
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This includes, but is not limited to, the following aspects of the project design and management:grading, utility management, stormwater management, sediment and erosion control, permits, and regulatory approval.
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POSTDOCTORAL POSITION available to study the role of inflammation in vascular and cardiac remodeling. The regulatory role of the resistin family of protein cytokines, on NLRP3 inflammasome and their downstream pathways are actively being pursued at cellular, molecular and biochemical levels.
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Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of clinical strategy and the design of study protocols.
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The CRC follows protocol, institutional and regulatory requirements to assure accuracy of the study procedures being conducted. CRC conducts day-to day activities of multiple studies with respect to compliance, regulatory, recruitment, study site initiation, monitoring and close out throughout the course of the research trials.
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As well as preparation of compliance and regulatory documentation for local (i.e. the Institutional Review Board), state and federal (ex. Responsible for general administrative work related to assigned study(ies), including but not limited to processing subject reimbursements and incentives, inventory and ordering supplies, organizing billing of services, etc.
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Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus. Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.
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Strong experience in patient centered outcomes research: COA instrument development/psychometric validation, quantitative analysis of CObased clinical study endpoints, regulatory dossier development and submissions.
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From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Recruits study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments.
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The Project Engineer is responsible for designing land development projects from concept/study phases through construction and managing project tasks. The Project Engineer is responsible for designing land development projects from concept/study phases through construction and managing project tasks.
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Under the supervision of a senior staff from the Biostatistics group, the incumbent will work closely with colleagues from Data Management, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
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Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
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study regulatory jobs in Towson, MD
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