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Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the world's leading oncology research organizations conducting community-based clinical trials. It has conducted more than 600 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today.
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As a Digital Biomarker Lead you will be overseeing aspect of sensor-related research, from benchtop experiments to oversight of technical validation in large-scale clinical trials. By fostering collaboration and navigating regulatory pathways, you'll lead the development and implementation of verification and technical validation of novel digital endpoints, shaping the future of clinical research.
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Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing.
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You will focus on projects from the start of assay development to clinical trial implementation as well as data management to ensure we are obtaining high-quality data from our clinical trials.
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Essential Functions Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
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Collaborates with the Dana-Farber Harvard Cancer Center DFHCC quality assurance of clinical trials office in developing protocol specific materials. The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area.
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The Clinical Research Coordinator may coordinate device and drug treatment research trials, as well as observational studies conducted at Children's Medical Center, including but not limited to study set-up, implementation, fiscal monitoring, and data collection/entry.
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This innovative position bridges the gap between traditional biomarkers and cutting-edge digital technologies, driving the development and validation of novel digital endpoints for clinical trials.
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The Addiction Medicine Division at Hennepin Healthcare seeks a full-time Clinical Researcher (MD or other doctoral level clinician) whose addiction-related research interests include health disparities and safety-net populations, integrated models of addiction care in general medical settings, implementation science, health services research, or pragmatic clinical trials.
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Our studies combine techniques from behavioral science, machine learning, and implementation research and incorporate influences from other fields including economics, health policy, biostatistics, epidemiology and clinical medicine.
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PhD (6+ years' experience) or MS (8+ years' experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
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Proven track record of leading biomarker programs from conception through validation and implementation in clinical trials. As a Senior Scientist in Clinical Biomarkers, you will be a key player in their research efforts to develop therapies that combat neuromuscular disease.
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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 successful candidate will join a vigorous addiction research environment including the NorthStar node of the NIDA Clinical Trials Network, NIDA JCOIN site, the Health, Homelessness, and Criminal Justice Lab, investigators with smoking cessation and tobacco regulatory science portfolios, and the University of Minnesota's Addiction Neuroscience Medical Discovery Team.
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Based at Fred Hutch and reporting to the Project Manager, the Clinical Research Coordinator will serve as an integral member of the pediatric research program to manage bone marrow transplant, gene therapy and other pediatric clinical trials from start-up to close-out.
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clinical trials implementation jobs
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