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Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiations. The Protocol Project Manager (PPM) will work within a specified oncology disease program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and various departments within UCSF providing support.
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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. 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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Exciting opportunity to work as a coordinator in an ongoing cohort study and new clinical trials at the Center for Cardiac Arrest Prevention (CCAP). The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
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Provide guidance in interpreting the data from pharmacometric analyses, including PPK, exposure-response analyses, and other quantitative analyses, to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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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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Prepares for study visits: research bio-specimen collection order preparation/placement, laboratory and EKG order placement, scheduling of biopsies and scans, facilitating RECIST form completion from the investigator, AE and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD) and other tasks as needed to support the administrative conduct of clinical trials.
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Other areas of investigation include many aspects of pain research (NIH R34 study of biofeedback virtual reality therapy for pain, R34 study on opioid use disorder after surgery, industry funded clinical trials or investigator studies on SCS-Neuromodulation therapy, neuroimmunology of pain, and development of computational methods / models to better assess pain), as well as R44 SBIR funding for a respiratory monitoring device.
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This position will provide oversight and management for the day-to-day efforts of the Cancer Center Clinical Trials Office focused primarily on breast cancer research coordination in conducting study activities including complex protocols in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP.
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Work Flexibility: Hybrid Stryker is seeking to hire a Clinical Study Associate to support Joint Replacement Clinical Trials. 1+ years related clinical trial associate, clinical study associate, clinical research associate or clinical research internship related experience preferred.
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Description The David Geffen School of Medicine, Department of Urology is seeking to hire a Full Time Senior Study Coordinator for pharmaceutical and industry sponsored, investigator initiated, and NIH-sponsored clinical trials.
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The Clinical Research Associate (CRA) advises and assists University of Minnesota faculty members in their preparation, conduct, and management of clinical trials. The Code of Federal Regulation (CFR), Good Clinical Practice (GCP) guidelines, and National Institutes of Health (NIH) research rules set standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials.
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The primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials in cardiovascular and chronic kidney diseases.
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On the clinical front, we have a robust clinical research infrastructure and are supporting multicenter industry funded clinical trials, investigator-initiated studies and trials, including trials on postoperative ileus, postoperative nausea and vomiting, spinal cord stimulation, as well as NIH funded translational studies and studies to test a clinical monitoring device.
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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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