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Successfully manage CROs and establish relationships to develop biomarker assays, monitor assay qualification/validation at CROs, as well as bioanalytical/biomarker testing in the clinical trials.
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We are a diverse team of experienced physicians and clinical scientists who collaborate to delineate early phase clinical development strategies, design innovative phase I-IIb clinical trials, develop and validate novel surrogate endpoints, and translate scientific ideas to proof of concept studies in targeted patient populations.
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Early phase clinical/translational research expertise, including experience in designing, monitoring, performing and interpreting early phase clinical trials and solid knowledge of biomarkers, surrogate endpoints, biostatistics, and safety reporting.
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The Brain Modulation Lab is involved with several major NIH and industry-sponsored clinical trials and the Project Manager will support multiple active protocols, serve in the capacity of lead Clinical Research Coordinator of trial teams, maintain regulatory documentation, Standard Operating Procedures, and train staff members to ensure compliance.
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Core Responsibilities - Accounts Receivable/Payable: Regularly review contracts/budgets, create/maintain study calendars and manually gather data from MGH Cardiology study teamsEnsure timely clinical trials invoicing to industry sponsors which matches protocol driven procedures with patient accruals/visits to ensure appropriate invoicing and reimbursement.
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Advanced knowledge of FDA, EMA, and GCP/GLP/GVP/ICH regulations and guidelines applicable for clinical trials conduct and/or regulated drug development activities, including general compliance and audit concepts; and.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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BASIC QUALIFICATIONS Ph. D. in biostatistics or related discipline with 7+ years of experience with patient-reported outcomes, health economics, health technology assessment, and outcomes research methodology used in clinical trials and observational studies.
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The CICL provides cardiac imaging core laboratory services for large-scale national and international clinical trials. Minimum of 1 year of clinical experience in Echocardiographic lab in a hospital or outpatient set up.
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The Clinical Research Coordinator work within the Center for Head and Neck Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.
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Writing SAS programs using SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/STAT, and SAS/SQL to map raw clinical data to CDISC compliant datasets and create tables, figures, and listings reporting results of clinical trials for investigational medications.
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Desired: Clinical trials, case-control and cohort studies, statistical genetics, protocol monitoring, hierarchical, longitudinal, survival, categorical, nonlinear, and epidemiology. This position involves project management for the statistical analyses and programming of clinical trials from small investigator initiated studies to large scale international clinical trials.
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The neuro-oncologist will have opportunities to expand and lead the neuro-oncology clinical trials program and to collaborate closely with laboratory-based investigators on translational research studies.
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Serve as the SME for important toxicology/Safety topics in areas such as safety biomarker analysis, genetic, endocrine, reproductive toxicology, applications of scientific methods to delineate appropriate mode-of-actions on emerging safety issues and the assessment of human relevance of the nonclinical findings in support of the planned and ongoing clinical trials.
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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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The MGH PET Center is a cGMP registered Positron Emission Tomography (PET) radiopharmaceutical manufacturer which produces sterile injectable radioactive drug for diagnostic imaging procedures at MGH. We produce several different PET drugs for a variety of clinical and clinical research indications, including clinical diagnostic imaging of cancer with F-18 Fludeoxyglucose.
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clinical trials jobs Company: Ppd in Boston, MA
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