Merit Medical Systems, Inc.

Research Analyst

• Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents.
• Maintains multiple trackers for assigned clinical trials (essential documents, investigational product, trial supplies, study follow-up visits).
• Orders, prepares, and sends documents and materials to clinical trial sites and vendors (electronic and paper).
• Provides support to study vendors and assists monitors with outstanding action items and site visits when applicable.
• Collects and reviews regulatory documents for accuracy and compliance to SOPs, local and national regulations and guidelines; follows up to resolve deficiencies.
• Manages central IRB submissions and supports sites in IRB/EC submissions.
• Assists with development and oversight of study operational plans (e.g., TMF plan), study and site tools, and study documentation (informed consent, newsletters).
• Conducts study systems training(s) and contributes to clinical site interactions (enrollment updates, visit updates, clinical supply requests, issue resolution).
• Provides general support to Clinical Affairs and project teams, including meeting agendas, minutes, translations, and invoice receipt/review support.

Senior Clinical Research Associate