Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Fort Worth, TX (hybrid work schedule).
Job Title: Technical Documentation Specialist II (Contractor)
Pay Range: $37.86/hr - $41.43/hr (W-2)
The contract duration is initially 2 years with possible extension
40 hours/week, Mon-Fri
Job Description:
• Coordinate collection and processes essential trial documents between investigator sites and CRD, including preparation and/or facilitating IRB/IEC submissions.
• Ensure 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.
• Ensure 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.
• Ensure 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. Interactions include but are not limited to Global Clinical Site Development, Clinical Trial Lead, Clinical Site Managers, etc.
• May provide support before and during audits, both internal and external when applicable.
Preferred Qualifications:
• 2-plus years related experience
• Bachelor's degree in life sciences (medical, pharmaceutical, biology, chemistry or RN)
• 1-plus year of clinical trial experience (e.g., ophthalmology, study coordinator, etc.)
• Proficient in Microsoft Office to include Word, Excel, PowerPoint
• Excellent verbal and written communication skills
• Excellent organization skills with exceptional attention to detail
• History of working with multiple internal and external customers
