Medical Device Documentation Expert
5 days ago
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.
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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