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Experience working within a Clinical EDC system (e.g., OpenClincia, Medrio, Medidata Rave). Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
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Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring.
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Coordinate and facilitate the appropriate conduct of clinical research trials in oncology which may be supported by the NCI, industry, cooperative groups or HHC system alliances. Required to attend the respective system-wide Disease Management Team meetings and present the clinical trials to potential investigators.
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Lead data management for clinical trials from launch to closeout. Proficiency in Medidata Rave or similar tools. 5+ years in pharmaceutical/biotech roles managing multiple trials.
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Knowledge of GCP and regulatory compliance guidelines for clinical trials required. The Clinical Data Associate II (CDA II) will support data management activities for Abiomed sponsored studies throughout the lifecycle of the clinical study including start-up, maintenance and completion activities.
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Interact/collaborate with all physicians, other members of the health care team and participants/families across the system in a manner that supports the conduct of clinical trials. Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: Medidata, RAVE, IRIS, NSABP, GOG, RTOG etc.
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Prior experience in clinical research coordination or clinical research data management, and SignalPath, Complion, RedCap, Inform, Medidata RAVE, etc. Under general supervision of the Clinical Research Manager, the Clinical Research Professional provides data management support and assistance to theUniversity of Cincinnati Cancer Center Clinical Trials Office.
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The CRI serves as the core radiology resource for NCI multicenter clinical trials involving diagnostic or therapeutic radiology. Research studies range from prospective clinical trials to retrospective reader studies, clinical and imaging registries, novel imaging methods and imaging software, validation of biomarkers, radiomic feature analysis, and AI algorithm development and validation.
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In compliance with all regulatory, institutional and departmental requirements, performs patient screening, data collection and data entry for research protocols, databases and projects within Hartford Healthcare Cancer Institute, and ensures the data quality and integrity for each clinical trial.
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Over this period, the CRI has conducted clinical research trials and other research projects that have transformed the practice of radiology, informed the development of clinical practice standards, led to new device approvals, and changed healthcare policy.
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Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
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Under the supervision of the Biospecimen Lab Manager, the Senior Biospecimen Coordinator supports the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC) by providing comprehensive coordination and data management of specimen correlative trials according to current Good Clinical Practices (GCP), Good Laboratory Practices (GLP), internal standard operating procedures (SOPs) and University policies and procedures.
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Primarily responsible for the database design, setup, and maintenance of assigned clinical trials/projects in Medidata Rave. Experience with CDISC (SDTM); data collection requirements in oncology trials; and clinical data standards development and maintenance.
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The Oncology Clinical Research Nurse (RN) of Cancer Clinical Research Office (CCRO) is an integral member of the research team. Assist research account specialist of CCRO with clinical trial billing in the resolution of related queries.
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Strong knowledge of EDC and/or systems design (i.e., Merative Zelta (IBM Clinical), Veeva, Medrio, Rave, etc.) , Interactive Response Technology (IRT)/Interactive Web Response Systems (IWRS) and data warehouse technologies as applied to clinical trials.
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