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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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Clinical Research Coordinator will assist with creation of master trial file and obtain the appropriate signatures for the regulatory forms. Clinical Research Coordinator will recruit and perform study visits, enter data, resolve queries, facilitate specimens collection and shipment.
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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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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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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. Bachelor's Degree with 2 years of experience working in a clinical research (clinical operations) environment with 2+ years of direct "hands-on" TMF experience.
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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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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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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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Responsible for development and maintenance of Trial Master File (TMF), The RPM will have a dual report in to their disease group manager and PIs and to CTO Leadership to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted at DFCI. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration.
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Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
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Assist customers by researching and copying case file records, Serial Register Pages, Master Title Plats, and patent documents. Perform daily transfers of case file records among the Docket room, adjudication, land records staff, and the public visitors.
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Required Experience: 1+ years experience in research or clinical research settingPreferred Skills: Current 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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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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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 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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clinical research trial master file jobs Title: data operations
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