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Audits research studies, monitors study budgets, resolves complex data collection issues, and implements protocol-specific study recruitment plans. Monitors study budgets and orders supplies.
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You will be responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP.
$32.65 an hourExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Identifies data inconsistencies with respect to data standards compliance and proposes solutions that support data review/efficiencies including ensuring robust master dataset specifications and correct interpretation of protocol, analysis and CDISC compliance requirements.
$119,400 - $203,100 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Additional Skills & Qualifications:· Data extraction from source documents and assist CRC with query resolution· Basic knowledge of clinical trials and medical terminology· In-depth understanding of departmental, protocol, and study-specific procedures· Proficiency in MS Windows and Office applications (Access, Outlook, Excel, Word)· Excellent interpersonal and communication skills· Strong attention to detail and ability to work independently.
$25 - $30 an hourExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. Department BSD CRC - Lab SupportAbout the Department The Clinical Research Center (CRC), a program of the Institute for Translational Medicine, is an interdepartmental, interdisciplinary resource that provides clinical space, services, and highly skilled expertise to faculty investigators and study teams engaged in the conduct of research with human subjects.
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Assist with the training of staffDevelop preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processesAssist with financial /operational aspects of grant and contracts.
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form. The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information.
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Element has a current opening for a full-time Research Clinician to join our growing team in Boulder, CO. The main responsibility of the Research Clinician is to assist the Clinical Study Manager in facilitating the Study in each Laboratory in order to meet customer turn time and requests; to help ensure the Studies are performed to protocol(s) requirements; to ensure that the Studies meet requirements of the Quality System.
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The Clinical Research Coordinator is responsible for the efficiency and accuracy of clinical studies through all stages as the study progresses and show vigilance in participant safety, protocol compliance, and data quality.
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Provide recommend and implement risk mitigation strategies to ensure proactive management of protocol/GCP compliance and data quality by the CRO and investigator sites. Manage site and study CAPAs to the quality resolution and closure and implement preventative risk mitigations and CAPA effectiveness checks.
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Proven track record in the delivery of successful major filings (NDA / MAA / J-NDA / China NDA), preferably in different therapeutic areas strong depth and breadth of knowledge of the submission process and significant experience in writing highlevel summary documents for global registrations; experience in process development and preparation of key regulatory documentation such as protocol development, clinical study report, Investigator Brochure, and safety aggregate reporting.
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Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
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Core Responsibilities - Accounts Receivable/Payable: Regularly review contracts/budgets, create/maintain study calendars and manually gather data from MGH Cardiology study teamsEnsure timely clinical trials invoicing to industry sponsors which matches protocol driven procedures with patient accruals/visits to ensure appropriate invoicing and reimbursement.
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Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows. Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates and tracks research activities across sites.
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Conduct cognitive, diagnostic, and clinical assessments of study participants, as well as caregiver interviews for clinical trials under the direction of a supervising Principal Investigator in accordance to FDA, GCP, and protocol guidelines.
Full-timeExpandApply NowActive JobUpdated 8 days ago
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