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The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials.
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The CICL provides cardiac imaging core laboratory services for large-scale national and international clinical trials. Working under the supervision of Harvard Faculty Directors, the Echo Tech II will be an integral member of the CICL and will assist with high-level, complex research including but not limited to echocardiographic analysis and data quality assurance.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Oversight and/or development of sample testing plan and delivery of high-quality biomarker data packages to inform clinical development and regulatory strategy.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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Acts as central steward of data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, considering the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive data science modeling tasks.
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Act as the medical monitor for clinical studies, reviewing patient data on an ongoing basis and meeting with investigators to develop an understanding of the safety profile and antitumor activity of new immuno-oncology agents in development.
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MelroseWakefield Hospital and Lawrence Memorial Hospital are distinguished by the range of high-quality clinical care and services. Activities may include data collection, analysis and evaluation.
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Maintain working knowledge of federal Human Subjects System (HSS) and Clinical Trials.gov to assist with entry and troubleshooting of clinical trials and human subjects data.
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The Director, R&D Quality, GCP consults as necessary with quality and study teams on advanced GCP quality assurance oversight and management activities to ensure the highest level of compliance in Vertex CGT clinical trials are in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System.
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Data generated by epidemiological studies is critical evidence needed to support clinical development (planning for Phase 3 efficacy trial, including a series of studies to determine incidence and risk groups to inform Phase 3 methodology and identify trial sites), to obtain optimum Vaccine Technical Committee recommendations, schedules, and public payer option, and to develop studies for post-licensure vaccine effectiveness which are pivotal to fulfil Pfizer’s regulatory commitments.
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Must have good work experience knowledge in ADLS ADF Snowflake Databricks Azure AIML Purview APIs Collibra Data processing in Azure cloud. Minimum of 15 years IT experience in Data BIA solution architecting of which at least 3 years in Azure Snowflake Databricks.
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Analyze LIS data to confirm customer volumes, test menus and validation of project implementation and cost savings results. Collect and analyze before and after data points to ensure cost savings goals are met and customer sign-off in a timely manner.
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Calibration of dose meters (including dosimetric inter-comparisons for QA) and radiation equipment (accelerator monitor unit calibration) Beam data acquisition for treatment planning. - In collaboration with department director and Physics director participates in clinical education, training, and competency evaluations for medical physics, Dosimetry, and therapy staff.
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Works with Laboratory Supervisor and technician to schedule daily assignment pertinent to clinical study related protocols, provides backup-support during absence of technician and data manager (keying reports, etc.
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This includes requesting and reviewing EMR from partnering organizations to obtain pertinent member documentation (narrative notes, physical exam, lab values, vital signs, medications, diagnoses and clinical parameters, including health maintenance data.
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clinical trials data jobs Title: operations in Cambridge, MA
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