Job Description

Job Title: Technical Documentation Specialist II

Location: Ft Worth, TX

Duration: 24 Months

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.

Self-starter

Customer Focus

Action Oriented

Communicates Effectively

Collaborates

Preferred Qualifications:

Bachelor's degree in life sciences (Medical, pharmaceutical, biology, chemistry degree or RN)
*2 years related experience (e.g., business administration)

1 year 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
#TB_PH

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