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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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Experience maintaining an Electronic Trial Master File (eTMF). 3+ years of professional working experience as a Clinical Research Coordinator/Clinical Research Associate Working knowledge of GCP and FDA Regulations.
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We have openings for clinical research coordinators to best match your experience level. to collect all essential documents required before the site begins to screen patients to participate in the clinical trial.
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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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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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Supervise clinical staff to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Bausch Health SOPs. Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.
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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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Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF) Good understanding of US regulatory and compliance requirements for clinical research.
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The Phase 0 Clinical Trials Navigator will be responsible for reviewing Barrow Brain and Spine neurosurgeon clinics each week to identify individuals who may be clinical trial candidates and performing routine clinical research activities under the direction of the principal investigator, research nurse clinician, and research specialist.
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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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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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The investigator-initiated clinical trial management supervisor will work very closely with USC/Norris Cancer Center physician-scientists, various CISO services and teams, Data Science Shared Resource and other cancer center core services to ensure that IITs are of the highest quality.
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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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POSITION SUMMARY As the Trial Master File (TMF) Specialist, you will be responsible for the day-to-day management of TMF, including oversight of the review and approval of TMF documents and generation of reports to measure completeness, accuracy, and timeliness of the TMF. This role works very closely with Clinical Operations and other departments that have a contribution to the TMF for studies.
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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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clinical research trial master file jobs Title: clinical trial assistant
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