Zoning Research Analyst
Blew & Associates, P.A.
Senior Clinical Research Associate
Merit Medical Systems, Inc.
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob 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.
