Clinical Trial Assistant

Provides advanced support for the tracking of clinical trial related documents or materials, maintaining the trial master file, and assisting in the development of tools to help in the conduct of clinical trials.
Creates the Trial Master File (TMF) and/or Investigator site files; supports maintenance for the duration of the study, assisting in the file review and reconciliation process in preparation for audits and archival
Assists in the preparation, receipt, collection, tracking and review of essential documents to confirm completeness. Creates and maintains project-specific binders and related files as needed to house study records during the trial
Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required. Ensure that regulatory documents are updated in a timely and appropriate manner
Assists with the translation process of study documents
Attend clinical project team meetings and take minutes
Provides support to imaging centers, labs, supply, and other study vendors
Responsible for the shipment and tracking of trial materials (e.g. binders, manuals, etc.)
Responsible for the shipment and tracking investigational product
Constructs trial master file folders and is responsible for filing and maintaining up to date study documents
Orders, prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed
Performs in-house duties to assist monitors responsible for sites located outside of the United States
Assists with the development of site tools and clinical trial start-up activities
Provides general support to the Medical Affairs team
Performs other related duties and tasks, as required
Education and/or experience equivalent to a bachelor's degree
Strong verbal and written communication skills
Strong analytical and interpersonal skills
Strong organizational skills and the ability to be self-motivated and be detailed oriented
Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs
Knowledge of ICH/GCP including relevant Guidance documents from (FDA, ICH, and EMEA etc.)
Medical device experience
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies.
The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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