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As the Clinical Research Associate, you will independently monitor clinical trial data by Good Clinical Practices (GCP), ICH, FDA, and internal standard operating procedures (SOPs). Your responsibilities as the Clinical Research Associate will include:Review the performance of the trial at designated sites.
$65,000 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Clinical trial, oncology, patient recruitment, Study Oversight, Chart review, Pre-screening patients, Adverse event reporting, Oncology nursing, clinical research, regulatory, gcp, irb, edc, epic, clinical studies, recruitment.
$40 - $48 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Strong understanding of the Trial Master File structure (TMF) Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT) and may contribute to the authoring of systems requirements.
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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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Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL.
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Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). CTM, Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF.
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Proficient with the use of computers and Microsoft Office Suite of products, as well as experience with tools specific to clinical trial management (e.g., CTMS, EDC, IVRS, eTMF, financial management systems, etc.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Addresses electronic data capture (EDC) queries under guidance of the study coordinator. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation.
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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.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Participation in the protocol-specific data management database closure, project closure, and study Trial Master File archiving of all data management deliverables (e.g., subject CRFs, final query reports, final audit trial reports, interim and final raw data in Clinical Data Acquisition Standards Harmonization (CDASH), data from external sources/transfers, essential data management documents.
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Systems may include: - Clinical Trials Management System (CTMS); Business Intelligence (BI) and dashboards for CTMS; electronic Trial Master File (eTMF); Electronic Data Capture (EDC)/ Thesaurus Management System (TMS) and underlying systems; Clinical Outcome Assessment Repository (COAR); Metadata Repository (MDR); Clinical Data Repository (CDR); Electronic Document Management System (EDMS); and others.
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Collaborate and consult with the MRDC's technical supporting team on the technical problem troubleshooting and system upgrade and maintenance activities of the MRDC in-house's Clinical Research Data Management System (CRDMS) and its components (e.g., Inform EDC, Central Designer, Central Coding.
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Work with junior CTM for oversight of Trial Master Files (TMF) oversight plan and liases with CRO for annual quality check; ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents.
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Experience working in Drug Discovery, clinical trial conduct, clinical data management or related industries. Ability to establish and maintain effective working relationships with teams involved in study start up.
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Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; Oversees recruitment and retention; establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and/or adjudication committee setup.
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