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Performs recuts and additional stains including special and immunohistochemistry stains, as requested by a Pathologist Operates computerized laboratory equipment to fix, dehydrate, and infiltrate with wax, tissue specimens to be preserved for study by Pathologist Dispose of hazardous chemical wastes per regulatory guidelines Opportunity for sign on bonus and relocation assistance (case by case.
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About Safety AssessmentCharles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists Contract Research Organizations, and employees of Hackensack University Medical Center.
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The Clinical Research Operations Specialist II will be responsible for the management of virtual and multisite operations by ensuring adequate study start up, regulatory submissions and training of each of the study sites in preparation for site activation.
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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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Develops appropriate regulatory reports and associated documentation in accordance with institutional policies, procedures, and study specific processes. Prepares and submits regulatory documents for all submissions to St. Luke's Research and the IRB of record on behalf of investigators.
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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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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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ResponsibilitiesA day in the life of a Manager, Clinical Research Operations at Hackensack Meridian Health includes:Manages the Clinical Coordinators, Clinical Data Coordinators, Regulatory staff and other clinical trial support staff, assigns schedules and makes operational decisions regarding staffing levels, workflow, and coverage for clinical trials research.
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Pipeline responsibilities include: Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC. Review and provide feedback on SDTM Trial Design Domains Oversee the creation of SDTM define.
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Key areas of responsibility include research/clinical activities, protocol development and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility.
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Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
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Review documentation and generate artifacts to demonstrate compliance with relevant regulatory and customer requirements, related to circuit design, power generation, distribution functions, electromagnetic effects, and bonding and grounding.
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MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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Assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
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