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Assist with the collection of study data as required by the study protocol, specifically the CBH screening form, admission forms and release of information. Complete other study procedures such as weight/height, waist/hip circumference as specified on the appropriate flow sheets.
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Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Lead the development of the protocol and related documents and the development and delivery of the clinical study report to meet GCP, ICH and all AstraZeneca quality standards.
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You will author the drug supply section of Clinical Study Protocol and lead the development of the master label text. Understand and translate clinical study protocol requirements into demand for drug products within a clinical study.
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Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports. In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
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Provides operations and strategic input and/or approves study documents such as synopsis, protocol, ICF, eCRFs, eCRF Completion Guidelines, Study Plans and Manuals, and Clinical Study Report development, etc.
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Serve as a voting member on the Inotiv Gaithersburg Institutional Animal Care and Use Committee (IACUC) including study protocol submission review, veterinary study updates at monthly meetings, policy and guideline review, veterinary perspective, facility program review and inspections.
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Be available to complete mandatory web-based home study training sessions before in-person training. The primary role is to review medical records in a sampled hospital's emergency department(s), abstract specific information from the patient's chart following the project's case identification protocol, and entering the information into a data collection tool.
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Determines data collection requirements based on the study protocol and system knowledge, makes recommendations based on previous experience. Creates and/or reviews study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards.
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6) Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and makes appropriate recommendations to Division of AIDS (DAIDS) leadership to ensure trials are conducted according to protocol.
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Be compliant with infection control procedures and environmental safety protocol within a facility. Build a strong physical therapy program Enhance clinical expertise, professional and management skills through interaction with managers, therapists and other professional staff, self-study, and other continuing education activities.
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Ensures centrifuge settings are appropriate for processing according to protocol. Assist the laboratory manager in site preparation for study conduct. Pack and properly label all study materials for storage or return to sponsor upon study close out.
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The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocity’s SOPs.
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Assist investigator in verifying that research study objectives are met on time, within budget and according to application protocol requirements, clinical research regulations and quality standards.
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Implements statistical programming aspects of the protocol and the clinical development program. Responsible for supporting and/or leading the statistical programming deliverables for a clinical study or project.
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