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Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality. Maintain key vendor relationships such as EDC System Vendor, Statistical Group etc. Assist with study start up including protocol review, case form design, database design, data specifications, data transfer specifications, and review data management and handling plans.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Responsible for working closely with internal and external functions, such as Programming, Biostatistics, Regulatory Affairs, and Project Management. Study documentation production and maintenance, data processing, data review.
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Solid knowledge 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, etc.) Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Proficient knowledge of study specific therapeutic area to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development) appropriate Policies, Standard Operating Procedures (SOPs), study specific requirements, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and applicable local regulations.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Familiarity with clinical research software and electronic data capture systems (e.g., EDC, CTMS). Ensure compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and other relevant regulations and standards.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Master Data Management, Regulatory, Quality, OpenData, Safety, R&D, Study Startup, Clinical Data Management, CTMS, Oncology Data, eTMF, Clinical Operations, Events Management, Territory Alignment , Multichannel CRM, Customer Reference Data, Cosmetics, Consumer Goods , Chemical, Animal Health , Remote Engage Meeting, Medical Devices, EDC, CDB, Vault Coder, Vault Payments, Vault QMS, Quality Docs, and Medcomms.
$85,000 - $225,000 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Clinical research, Clinical trial, Pre-screening patients, EDC. Knowledge of federal regulations and Good Clinical Practices (GCP) Clinical research, Clinical trial, Pre-screening patients, EDC.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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This includes Source Data Validation (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) with the Electronic Trial Master File (eTMF), ensure proper documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.
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Solid understanding of the drug development process, including Good Clinical Practice (GCP) and FDA Code of Federal Regulations. The Clinical Research Monitor works in partnership with the AFT Project Manager and individual study teams to complete all site monitoring activities across assigned AFT projects and ensures all participating sites are compliant with Good Clinical Practice (GCP), SOPs, policies, and regulatory requirements throughout the life of assigned clinical trials.
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Perform remote and on-site monitoring & oversight activities in accordance with protocol, GCP/ICH Guidelines, and AFT SOPs. Verify that trial data entered in the EDC is consistent with patient clinical notes and other source documentation (SDV.
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Monitor clinical trial progress, in conjunction with the AFT In-House Clinical Research Associate (IHCRA), through a combination of remote data review and remote/on-site monitoring visits. The Clinical Research Monitor will work under the Executive Director of Clinical Trial Operations and the Associate Director of Clinical Trial Operations to oversee activity at Alliance for Clinical Trials in Oncology sites participating in Alliance Foundation Trials (AFT) clinical trials.
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Excellent organizational, leadership, and problem-solving skills. Manage on-site medication accountability and inventory throughout clinical study. The Clinical Research Monitor will be responsible for monitoring activities across multiple protocols.
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Support the study specific operations team with communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
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Strong familiarity Medidata RAVE, Veeva EDC or Medrio. Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Good Clinical Data Management Practices (GCDMP.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging.
RemoteExpandApply NowActive JobUpdated 22 days ago
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