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Lead the study start-up process, including, but not limited to, the Trial Kick-off meeting, the set-up of the trial master file (TMF), the set-up of the electronic data capturing (EDC) system, site selection, and the finalization of site Clinical Trial Agreements and budgets.
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Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy.
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Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF) In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material.
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Trial Master File Records Specialist (TRS) Responsibilities. The TRS will provide services onsite (hybrid position) at our Ridgefield, CT location supporting our Trial Master File (TMF) team.
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Why LMK:LMK Clinical Research Consulting is a recognized leader in Trial Master File (TMF) document management services and solutions for the life sciences industry.
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The Clinical Trial Rater, a mental health professional, will be solely responsible for interviewing research participants and their informants/caregivers who are being evaluated to participate in a research study for various cognitive and behavior disorders.
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The Clinical Study Associate primary responsibilities include but are not limited to supporting device supply logistics, financial processes (contracts, budgets, and invoices), essential document and trial master file (TMF) management and select monitoring activities.
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Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File. Assist in training new research staff regarding research compliance, including presentations sessions.
$55,200 - $96,600 a year depends on experienceFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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Manage site regulatory documents and Trial Master File (TMF) The Coordinating Center Senior Project Manager for the Center for Clinical Investigation Coordinating Center (CCI-CC) will report to and work closely with the CCI-CC Director in the development, implementation, and management of the clinical trial operations for ongoing clinical trials and research consortiums.
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The primary clinial trial for which the Clinical Research Nurse will be responsible for is a single-center, open label, non-randomized safety and efficacy trial to evaluate co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression (PARADIGM.
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The Clinical Research Coordinator I works independently providing study coordination, 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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Stay current with scientific literature and emerging technologies in the field of immunohistochemistry and clinical trial research and advancements in IHC technologies, biomarker discovery, and regulatory requirements for companion diagnostics, and integrate new methodologies into development strategies.
$120,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsible for development and maintenance of Trial Master File (TMF) The Division of Rheumatology, Allergy and Immunology (DRAI) at Massachusetts General Hospital (MGH) is seeking an intellectually curious and highly organized individual with supervisory experience to serve as a Research Project Manager in a clinical trial which will test two different treatment strategies for gout.
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Working Title : Clinical Research Coordinator I - Obstetrics & Gynecology - Accortt Lab (Full-Time) Maintains research practices using Good Clinical Practice (GCP) guidelines.
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clinical research trial master file jobs Company: Bausch Lomb
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