Merit Medical Systems, Inc.

Senior Clinical Research Associate

Merit Medical Systems, Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States

Visit company website
✨ AI Apply
Manual Apply

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.

Requirements

  • Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification.
  • Minimum of six (6) years of related work experience.
  • Current Good Clinical Practice (GCP) certification.
  • Knowledge of US regulations, Good Clinical Practice and ICH guidelines.
  • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
  • Clinical trial experience.
  • Preferred: Medical Device clinical trial experience.
  • Verbal and written communication skills.
  • Organization; Detail-oriented; Project task team participation.
  • Physical/environmental demands: Lifting not to exceed 50 lbs.; Writing, Sitting, Standing, Bending; Visual acuity, Color perception, Depth perception, Reading, Field of vision/peripheral.