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Experience with research (development of research questions and study design/protocol development) and conducting statistical analyses of clinical measures/biostatisticsFamiliarity with drafting of tables and or figures for publication of research findings Compensation Information This position is classified as "non-exempt, hourly" and is assigned to pay grade 24.
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This person will play an active role in TMF maintenance, provide input on clinical trial protocols, study reports, develop study audits, assess protocol deviation, study document review, review and approve clinical trial plans.
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As a Clinical Research Associate you will be responsible for a variety of monitoring tasks and you will have a chance to work on clinical studies in different therapeutic indications, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and the applicable regulations and SOPs.
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As the Lead CRC, you will act as the subject matter expert and leader of a clinical trial team to conduct and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Eximia Clinical Research’s SOPs.
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Support trial study start-up phases (support in writing study protocol, identification of investigators and KOLs, CRF review, Investigator brochure review, FDA/CA & IRB/EC assistance, support on medical and scientific questions/issues during trial follow-up phase.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on study deliverables.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Study start up, ensure all protocol requirements are met, ordering of proper supplies, development of vendor relationships, coordinate staffing and proper coverage. Manage and track vital trial metrics and operational objectives for the trial are in conformance to all relevant laws, regulations, GCP guidelines, protocol, and internal SOPs/policies.
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Collaborate with Protocol Activation office to initiate and activate all new clinical trial protocols assigned utilizing Oncore Study-start up task list. Demonstrate basic knowledge to accomplish core tasks such as recording and reporting Serious Adverse Events (SAE) in a timely manner, accessing protocol attachments via OnCore™, enter charts into Medical Records Database, formatting, and printing patient study calendars, etc.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Review and tracks progress of clinical trial, essential regulatory documentation from clinical sites before study start-up and throughout study conduct, such as financial disclosures, debarment checks, current CVs, GCPs, relevant certification and licensing requirements.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Familiarity with study design, protocol documentation, and review (e.g., IRB) procedures. Familiarity with biosignal data collection and study design procedures. Participant Engagement in a Human Computer -Interaction (HCI), User Experience Research (UXR) or other Human Subjects Research (HSR) environment.
ExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Lead development of clinical trial protocols and protocol-related documents (e.g., ICF, CRF, Assist with strategic insights, literature research, regulatory filings, site and investigator relationships, study data tracking and analysis, preparation of presentations and publications.
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As biostatistician you will be responsible for providing statistical support for the study protocol development, analysis plan and supporting cross functional teams. Make an impact on the future of cancer care, using a bold approach to drug discovery and development, as the next contract biostatistician joining a clinical-stage biotech.
ExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Performs clinical study site management/monitoring activities in compliance with Good Clinical Practice (GCP) / International Council for Harmonization (ICH), Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
ExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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The Clinical Scientist will support various aspects of Clinical Development, encompassing assessment of unmet medical needs, evaluation of disease states, study design, protocol development, study oversight, data review/interpretation, and overall support for drug development initiatives.
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Tangible working experience and use cases of: PHY and MAC level simulations, firmware development, and work with equipment such as wireless test equipment, Protocol analyzer, PHY level test equipment.
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protocol study jobs in New Orleans, LA
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