The Study Intake Coordinator is responsible for the initial receipt of clinical research study application submissions, continuation renewals and modifications for the Institutional Review Board (IRB) review. This includes the electronic receipt of submission and conversion to paper-based submissions to the Institutional Review Office (IRO).
Responsibilities and essential job functions include but are not limited to the following:
- Receive electronic submission packets submitted to a central email queue.
- Determine and manage priority of submissions in central queue for processing.
- Create study specific folder on the central file server.
- Transfer all study related documents to the central file server, assign appropriate tracking numbers and log submission into tracking system(s).
- Using the appropriate quality screener, verify that the submission form has been completed and meets the minimum criterion and that all required attachments are submitted.
- Complete appropriate forms and communicate with study teams to obtain additional required information.
- Notify department personnel that the submissions are ready for additional review(s).
- Prepare IRB submission packets including printing, collation, scanning, and routing to the Institutional Review Office via mail courier.
- Receive IRB responses including scanning, routing to study teams, and electronic storage of these files in accordance to version control standards.
- Post approved documentation to an Adobe Acrobat formatted secure website for use by study staff ensuring that documentation is complete and appropriately linked.
- Provide submission support activities as assigned.
Summary of Experience
- Bachelor's degree preferred.
- Minimum 2 year relevant experience requiring attention to detail and accuracy, ideally within research or medical field.
Required Knowledge and Skills
- Minimum keyboard speed of 45-50
- High proficiency with Microsoft Word
- Experience with Adobe Acrobat
- Experience with electronic file management
- Experience operating and validating scanned documents
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