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Coordinates scheduling and set up for audits and all Monitor, study start-up, and close out visits. -Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures.
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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.
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Study documentation production and maintenance, data processing, data review. Minimum of 5 years of medication, clinical, or research related study or instruction or proven in role success equivalent to required years of experience.
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As a Research Assistant, you will also be responsible for performing the task(s) as per clinical trial protocol, ICON Early Phase Services SOPs, FDA, ICH GCP, and utilizing proper source documentation techniques; and participate in clinical trial meetings and training as warranted by the study protocols.
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The Research Assistant is integral in the execution of all aspects of the clinical trial, will have direct patient contact and is responsible for ensuring that all clinical trial activities are performed as outlined by the clinical trial protocol.
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Study Team Leader and primary operational contact for 1-3 trials of average design and protocol complexity, including clinical trials, Rx-to-OTC Switch & associated behavioral studies, and decentralized/virtual trials.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents.
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Education: Bachelors in Sociology, Psychology, Nursing, or field study related to the research of the clinic. The Clinical Research Project Coordinator adheres to good clinical practices, study protocols, and applicable regulations; conducts complex work and contributes to measurable team objectives; and uses discretion to provide solutions to issues.
$56,000 - $62,000 a yearExpandUpdated 23 days ago - UpvoteDownvoteShare Job
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Performs an array of assigned duties including investigator site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements.
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Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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Provides effective crisis management, to include following the program triage protocol and treatment methods, responding in a timely manner, providing for follow-up care, assessing and providing appropriate responses, and handling the situation calmly.
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You will support the Clinical Research Coordinator and/or Senior Clinical Research Coordinator in planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations.
$26.29 - $42.28 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Overview: As a Clinical Research Vision Examiner, you’ll be responsible for completing the certified vision tasks for each study protocol they are assigned to, processing research referrals, printing and mailing informed consents to patients that have been referred to the research department.
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Substantial clinical study protocol experience, as lead author, required. Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.
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Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials and publications to medical journals.
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