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Utilize knowledge of clinical data research methods, such as Trial Master File (“TMF”) to track critical clinical research documents and ensure proper recordkeeping and filing according to federal and global regulatory standards.
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Responsibilities Include: Conducting all trial visits Completing all study-specific assessments (e.g. vital signs, EKG, blood collection) Processing all samples and shipping to Central Lab Maintaining study source Entering data into sponsor EDC and query resolution As the sole Senior Clinical Research Coordinator (SCRC) on-site, the chosen candidate must be adept at protocol comprehension and be capable of working autonomously.
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Assists in the development and maintenance of a detailed schedule of QA/Reg milestones and deliverables; to include internal audits, quality improvement projects, Trial Master File (TMF) reconciliations, etc.
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Exceptional matrix team leader, ability to interface with leaders across the enterprise and project teams to develop long range plans and budgets for clinical biomarker pathology technologies aligned with company objectives, identify, pilot and establish new pathology related technologies to meet drug development needs in Ph 1, Proof of Mechanism/Concept, and in registrational clinical trials.
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The research trials may include treatment trials, biomarker trials, imaging trials, neurocognitive and motor control studies and other research. IRB review process, informed consent, trial design, data monitoring as well as good writing and editing skills a plus.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation.
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The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions.
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Strong scientific background in immunology or related field supported by publication record in these areas Expertise in dermatology or rheumatology highly desirable Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro diagnostics, protocol design, and/or experience in development strategy preferred.
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Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusions growing pipeline of RCs. Summary:The Senior Clinical Trial Associate is responsible for supporting the Clinical Operations team to execute on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials.
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Ensure that the Trial Master File (TMF) is maintained and up to date. Ensure that clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with argenx procedures, ICH-GCP and other applicable legislations.
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Ethics and Values: Communicates and demonstrates the ethics and values of the Probate and Family Court Department and the Trial Court. Mission: Understands, upholds, and communicates the Trial Court and Probate and Family Court missions.
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Responsible for development and maintenance of Trial Master File (TMF),Assists PI with protocol and consent form development for initial application and with subsequent amendment changes.
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Reporting to the Head of Clinical Supply Chain, the Associate Director of Clinical Supply Planning will focus on managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials.
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Our research aims to improve quality of life, well-being, symptom and pain management, and reduce caregiver burden:For example, a Clinical Research Coordinator to support a large multi-site clinical trial study that focuses on the comparison of care delivery models to support older adults with complex healthcare needs.
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Knowledge of clinical research budgeting and the clinical trial life cycle: study start-up through study closure. The Medicare Coverage Analyst (MCA) is responsible for reviewing clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other relevant study-related documents to create a coverage analysis/billing guide.
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clinical trials trial master file jobs Title: trial master file in Boston, MA
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