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Posted: 19-Aug-24
Location: Irving, Texas
Salary: Open
Categories:
Internal Number: 212572
Summary:
Under general direction services as the primary regulatory resource for investigators and staff. Primary coordination responsibilities include dissemination of information about and assistance to investigators in the preparation of IRB applications. The position coordinates the preparation of applications for presentation to the IRBs and will independently determine the adequacy of the application and the level of review required (exempt, expedited, full board).
Responsibilities:
- Screen new and renewable applications; contact and advice investigators in preparation and completion of application process
- Prepare meeting agendas, assigns applications to IRB committee(s)
- Prepares IRB member packets and distributes them prior to the IRB meeting
- Maintains study annual renewal system to include preparation of tickler reports
- Preparation and dissemination of reminders and appropriate forms, advises investigators and staff as required
- Closes out study applications to include appropriate forms and preparation of files for final reports for closure
- Prepares study withdrawal applications when required
- Prepares and finalizes applications to include filing
- Prepare IRB meeting minutes
- Prepares and distributes IRB meeting approval, renewal, termination, and contingent approval letters
- Assist other coordinators when necessary with similar duties
Requirements:
- Bachelor's Degree
- Experience in using computer hardware and standard computer software programs specifically IRB system processes platform.
- 1 – 3 years of experience
- An active CIC acquired within 1 year of employment.
Work Type:
Full Time
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