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The Principal Clinical Research Associate (CRA) is responsible for the day-to-day management of a global clinical study. Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG.
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The CRA II will be responsible for the study start up process for AtriCure’s Clinical Investigational protocols, which includes and is not limited to the following: protocol review, Informed Consent Development, CRF design, EDC testing, preparation of site-specific logs/documentation and investigator study files.
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MN Urology is seeking a Summer Clinical Research Intern. Uploading and entering information in a Clinical Trial Management System, eSource Data System, e-Regulatory System, and/or Document Control/Learning Management System.
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The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds.
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Hands-on experience working in Medidata Rave EDC or another EDC system. Experience with other clinical trial technologies (RTSM/IVR, CTMS, eTMF, ePRO, eCOA, Argus) along with integration design practices.
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And minimum 7 years global Drug Safety/Pharmacovigilance clinical trial and post marketing experience in a pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility.
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Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification. Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification.
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The Senior GI Research Coordinator will carry out the day-to-day operations of the GI Research Department including research operations and clinical activities, and will take a lead role, along with the PI, in the recruitment and enrollment of patients into research studies.
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Use experience with: SAS and programming languages for derived analysis datasets and TFLs; XML, Pinnacle 21; handling and processing of upstream data (multiple data forms, workflow, eDC, SDTM); providing outputs to meet downstream requirements (ADaM, Data Definition Table, e-submission); and CDISC standards and relational database to p rovide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of BMS products.
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Champion people, process and technology improvements and standards to enhance quality, increase productivity (internal and external with Investigator sites) and reduce data latency within Quintiles clinical trial systems inclusive of IVxS, EDC, CTMS, QRPM, Data Factory, Triggers and Alerts, Visualizations such as Infosario Analytics and Federated reports, CDOS and SLDRs.
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The Sterile Processing Technician (certified and non-certified) provides the foundation of the peri-operative services as well as most clinical departments throughout the hospital and within the community.
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Experience working in Drug Discovery, clinical trial conduct, clinical data management or related industries. Provide expert skills as part of a Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs.
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Create specifications and work with internal software teams to design highly efficient tools to organize and report on clinical and analytical study data from multiple sources (hard-copy CRFs, EDC systems, SLC BIOFIRE run database, Microsoft Excel spreadsheets, etc.
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Strong experience of EDC systems, especially Medidata Rave. Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases.
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Monitor quality of data deliverables from external vendor sources used for the clinical database for all assigned studies with focus on assessing and producing metrics on overall database trends, including but not limited to EDC, eTMF, etc.
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