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Closely and liaise with the clinical operations team, clinical study teams, pharmacovigilance, the SVP and stakeholders. Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in strategy development and protocol design.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Conducts operational clinic procedures and trains staff to conduct procedures according to study protocol, GCP, FDA and OSHA regulations. Interacts with study sponsors, regulatory agencies, and UMMC compliance department on behalf of the study.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Nuclear Medicine Imaging Specialist is responsible for assisting in the delivery of IE’s central reader training, study procedures and protocol criteria when required. Provide training to Radiologist, Oncologist, and other sub-specialty Physicians onImaging Review Charters/Reader Rules Reader Rules Image Analysis Platform Protocol-specific assessment criteria Monitor/evaluate reader results to ensure compliance with protocol criteria and CRF completion requirements.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Provides protocol specific training to study team, investigators, clinical research associate, and others. With supervision of medical monitor (director/Sr director) provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
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In conjunction with the Patient Care Manager and Clinical Research Coordinator, collects and maintains protocol information/data and documentation to ensure that research study protocols are appropriately applied and that study patients are monitored and reported as required.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
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Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. 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.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Under direct supervision, the Research Coordinator will perform duties related to the support of research projects, including protocol development, drafting regulatory documents, participant recruitment, screening participants for eligibility, consenting of participants, training participants on study procedures, and conducting and scoring assessments.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Informs investigators and study staff of institutional policies and procedures that support protocol compliance, patient safety and clinical operation's efficiencies. Supports investigators and study teams in adverse event assessments and documents appropriately for protocol required data entry.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
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The position supports a leadership team focused on study management, resource utilization, data integrity & systems usage, protocol compliance, participant accrual and subject safety. This role will work with the manager of the Clinical Research Unit of the Outpatient Infusion Room in collaboratively defining procedures and processes, and developing SOPs for clinical research conduct; this role will be a resource for the unit regarding operational issues for protocol execution and compliance within the CRU, with guidance from the CNO Supports the Director/VP with ongoing development of departmental strategies that support the research mission.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Adheres to good clinical practice, and complies with regulatory and grant agency requirements, and study protocol; maintains study records and collaborates with the institutional review board as necessary.
$58,540 - $92,650 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Responsibilities:Engage in the process of choosing CROs, advisors, and additional service providersPlay a role in management choices regarding resource needs and approach for study teamsOversee that studies are carried out following the protocol, ICH-GCP guidelines, regional regulations, and relevant standard operating procedures (SOPs)Contribute to the creation, upkeep, and refreshment of SOPs for Clinical Operations and Clinical DevelopmentGuide less experienced personnel when necessary.
$140,000 - $160,000Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality clinical trials including protocol development, medical review, oversight of study conduct, data quality and safety is preferred.
ExpandApply NowActive JobUpdated 6 days ago
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