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Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board. The Clinical Research Coordinator (CRC)1 will be involved in multiple aspects of research project(s) in the Mother Infant Research Institute as laid out below and per discussion with the PI. The Mother Infant Research Institute aims to enhance the lifelong health of mothers and babies by building, growing and training a community of collaborative researchers with a multidisciplinary perspective.
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Responsible for scientific leadership and execution of clinical studies, ensuring high-quality trial execution, data review, safety assessment, and interpretation of results. Serves as a technical resource for clinical issues, oversees data generation and validation, and conducts data review and analysis.
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The Clinical Research Coordinator, Level 1 (CRC1) is a research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities. Reporting to the Hospital Administrator and to the Research Programs Office at SHC International Headquarters, the CRC1 provides support in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice.
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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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Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. 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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The Pre-op Review Nurse evaluates preoperative optimization of scheduled surgical patients via telephone screening calls and by reviewing pertinent clinical documentation. The Pre-op Review Nurse needs to have strong critical-thinking skills, a comprehensive nursing background, and good interpersonal and communication skills.
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Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy. Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lock.
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The clinical research coordinator (CRC) will assume the responsibility for overall study coordination for research conducted within the Division of Addiction Psychiatry and its collaborators. Preparing study reports, annual reviews, NIH reports, and Institutional Review Board (IRB) documentation, including reporting of adverse events.
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Supports disposition activities for manufactured products in support of Commercial/Clinical Product, including Master Batch Record review, Executed Batch Record review, resolution of comments/issues and Certificate of Analysis review.
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Author and review scientific publications, regulatory documents, and presentations related to biomarker research. Proven track record of leading biomarker programs from conception through validation and implementation in clinical trials.
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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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Ensures a robust framework for the quality oversight, review and approval of Quality Management System (QMS) standards and procedures for regulated activities in Clinical Research (GCP), Pharmacovigilance (GVP) and Medical.
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The highly-qualified Biostatistician will support clinical investigation with a focus on genetic studies, including design and analysis of clinical studies, estimate sample size and power, interpret results and write statistical sections of papers and grants collaboration with investigators affiliated with Harvard Medical School, grant and protocol development and review, and teaching and mentoring of junior investigators.
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This position is responsible to review and investigate denials from the Medicaid/MassHealth administrator(s), i.e. Dentaquest, resubmit claims, processing adjustments to accounts within system, including write-offs and billing to the patients, as appropriate.
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Review, update, or write company SOPs in partnership with the pharmacovigilance and clinical team related to Pharmacovigilance and clinical trials to ensure their compliance with EMA, ICH, and FDA guidelines.
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review clinical jobs in Boston, MA
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