Medical Device Documentation Expert

5 days ago


Fort Worth, Texas, United States Source One Technical Solutions Full time
Job Overview

We are seeking a highly skilled Medical Device Documentation Expert to join our team at Source One Technical Solutions. This is a unique opportunity to work as a consultant with a global medical device company in Fort Worth, TX.

Key Responsibilities:

  • Coordinate the collection and processing of essential trial documents between investigator sites and CRD, including preparation and/or facilitating IRB/IEC submissions.
  • E nsure accuracy and quality of site documents included in the site initiation packets and throughout the duration of the study.
  • Enter and maintain site information and document tracking in current clinical trial management systems.
  • E nsure trial documentation is well organized, available, current, and archived in a timely manner in the sponsor Trial Master File and ensure audit readiness.
  • Follow applicable work processes, SOPs, communication plans, etc.
  • E nsure timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budget and contracts, or other relevant documentation.
  • May interact with and advise other functions on CTDM responsibilities, including Global Clinical Site Development, Clinical Trial Lead, Clinical Site Managers, etc.
  • May provide support before and during audits, both internal and external when applicable.
Requirements

To be successful in this role, you will need:

  • A minimum of 2 years of experience in clinical trials or a related field.
  • A Bachelor's degree in life sciences (medical, pharmaceutical, biology, chemistry, or RN).
  • Proficient in Microsoft Office, including Word, Excel, PowerPoint.
  • Excellent verbal and written communication skills.
  • Excellent organization skills with exceptional attention to detail.
  • A history of working with multiple internal and external customers.

Estimated Salary: $38.65 - $42.53 per hour (based on location and industry standards).



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