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The Master Fleet Technician's primary purpose will require the individual to perform preventative and corrective maintenance on fleet vehicles and equipment including gas and diesel engines, hydraulic systems, air brakes, forklifts, tankers and trailers.
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Knowledge of Trial Master File (TMF) or Electronic Data Capture (EDC) systems is a plus. Applies regulations which include but are not limited to GCP, GLP, 21 CFR Part 58 and 21 CFR Part 11, guidance document requirements, and study plan/protocol requirements to Preclinical and Clinical trial studies.
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Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). Provide clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
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Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
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Ownership of TMF and eTMF activities for assigned study; specifically track and manage study related activities, including Trial Master File (TMF) and electronic TMF (eTMF) study documents (including first pass quality review of documents as assigned), e.g., site monitoring visit reports, vendor/site agreements.
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Clinical Research Coordinator I supports the needs of local and federal clinical trial. Assists with compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements.
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Deep understanding of ALE/EDI IDoc’s, file-based interface, LIMS integration, MES integration, recovery of failed batch Jobs & Inbound & Outbound RFC & Queues. Expertise in QM master data and configuration for SAP Quality management processes - MICs, Batch management, Batch traceability, Class and Classifications, Dynamic modification, sample management, Inspection plans, COA profiles etc.
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Responsible for managing effective relationships with CROs and other vendors for all clinical trial activities, including study start-up, trial maintenance close-out phases, and completion of Trial Master File (TMF), with quality.
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Ability to operate equipment, reset complex escape rooms in under 5-7 minutes, operate game master software system, and multitask. Game master 3 rooms simultaneously while working to support the host or manager.
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Working within a team environment and leading functional internal audits of VO's electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO's documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
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Job Description UC Health is hiring a full time, remote Charge Master Auditor for the Charge Master Services Department. The Charge Master Auditor is responsible for executing charge related audits.
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Ph. D. or DrPH degree with experience in cancer clinical trials design and implementation of statistical activities during trial conduct. Ph. D. or DrPH plus experience in cancer clinical trials design and implementation of statistical activities during trial conduct.
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Uploads/downloads into those discovery databases documents and materials received from local, state, and federal law enforcement partners consisting of investigative and forensic reports, bank records, electronic communication records, and audio and video files provided in varying file formats.
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Legal Secretarial experience is preferred, but in some cases experience as a file clerk, receptionist, or project assistant will suffice. If you have experience at a Law Firm as a Receptionist, File Clerk, Administrative Assistants, Legal Support Assistant, or other legal support staff this job is for you.
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Diesel Tech; Jiffy Lube; Bumper to Bumper; Cummins; ASE; ASE Master; Diesel Vehicle Mechanic; Lead Mechanic; Freightliner; Heavy Equipment Mechanic; Diesel Lead; Automotive Mechanic; Auto Mechanic; Tech 1; Tech 2; Tech 3; Master Mechanic; Heavy Mechanic; Diesel Mechanic; Mechanical Knowledge; 91b; Engine Man; 2t3; Vehicle Maintenance; Auto Repair.
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trial master file jobs Title: clinical research associate Company: Parexel
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