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The Clinical Research Coordinator assists the clinical trials process by registering hematology, oncology, and bone marrow transplant patients for clinical studies, assessing eligibility criteria, maintaining current protocol packets and assuring that all quality assurance measures are maintained within the protocol/study.
$39,300 - $64,349 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Experience in clinical research, familiarity with oncology protocols, clinical trials operations, GCP, NCI guidelines and federal regulations both FDA and HHS. 5 Years' experience in clinical trials auditing.
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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. Accountable for planning, design, execution, and results of the Clinical Affairs Biomarker team & clinical trials program.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Serve as primary clinical point of contact with the US FDA and other foreign regulators and notified bodies, and act as Clinical Lead for complex FDA negotiations leading to successful new product clearance and approvals for the Biomarker program.
$185,500 - $235,500 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Extensive experience in leading statistical programming function for both early and late phase clinical trials, and regulatory submissions (NDA/BLA, MAA) Represents Rocket as Subject Matter Expert on clinical data submission in meetings with FDA and other regulatory agencies; and provides leadership in addressing clinical data submission questions/comments from FDA and other regulatory agencies.
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As a member of The US Oncology Network , one of the nation's largest community-based cancer treatment and research networks, Compass Oncology participates in leading-edge clinical trials through US Oncology research, which has helped develop 89 FDA approved cancer therapies.
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The coordinator will work on 10-15 clinical trials primarily within sickle cell disease. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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In executing these responsibilities, the Rater is guided by FDA regulations, Good Clinical Practice (GCP), relevant workplace practices, and company standard operating procedures. The Rater is responsible for the organization, administration, management, and efficient execution of clinical ratings associated with clinical trials.
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Complies with GCP's (Good Clinical Practice) guidelines and follows all FDA regulations with regard to clinical trials. Performs accurate documentation of screening and/or enrollment necessary to meet legal standards and FDA requirements.
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Define and manage phase appropriate QA activities in support of preclinical studies and clinical trials. DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials.
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Collaborates and supports Yale Center for Clinical Investigation (YCCI) Quality Assurance & Monitoring team on regulatory authority (e.g.: FDA, EMA) inspection preparedness for CTO supported trials as needed.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Assists investigator with consent process assuring patients understand clinical trials. Knowledge of clinical trials and the regulation (local, state, and federal) of such.
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Provides quality assurance support of validation, manufacturing, and testing of clinical trials materials and serves as a quality assurance resource for the Pilot Plant staff. Provides review of technical, validation and other protocols and reports, with emphasis on adherence to quality systems, and with FDA, EMEA, ICH and JP regulations/guidance.
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Knowledge of FDA regulations and GCP-ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of clinical research studies. The Senior Clinical Trial Project Manager will independently manage multiple Phase I-Phase II Penn-Sponsored clinical research studies in order to ensure execution of clinical research and oversee clinical studies from concept to final close, including study start-up activities, study monitoring activities, data collection, project maintenance and project close-out activities.
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Mathematical skills Sufficient to prepare clinical research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets.
$32.65 - $52.63 an hourFull-timeExpandApply NowActive JobUpdated 7 days ago
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