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Clinical Research Coordinator will assist with creation of master trial file and obtain the appropriate signatures for the regulatory forms. In addition to the responsibilities above, the Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting.
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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.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace.
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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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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system.
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Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists.
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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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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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Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File. Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva.
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Manage and provide oversight to the CDM section of the Trial Master File. Reporting to the Executive Director, CDM, the Senior Manager, CDM will be a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment, and will oversee data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals.
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Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
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Years’ experience: Minimum of two (2) years’ experience coordinating research protocols OR (2) years' experience in cancer research OR certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA.
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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 8 days ago - UpvoteDownvoteShare Job
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It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository.
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The TMF Specialist will provide subject matter expertise (SME) and support required to ensure that the Trial Master File (TMF) is audit and inspection ready. Demonstrated experience or knowledge with the clinical research process, including the collection of documents at study start-up, during study conduct and close-out.
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clinical research trial master file jobs Company: Anavex
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