Description
1. Assesses, develops, and revises research protocols and prepares materials for approval. Prepares/assists with initial contract reviews and confidentiality agreement review.
2. Prepares and negotiates study budgets. Tracks account activity, resolves discrepancies, works with ACRI to insure funds are collected per contract at study end and funds are disseminated per internal budget.
3. Facilitates inspections/audits. Develops QA schedule for projects, and performs QA activities, and develops improvement plans.
4. Delegates/assists with creation of flowcharts, source documents, and other study related materials. Manages collecting and recording subject data on case report forms process. Creates databases and manages data entry.
5. Leads others to use the clinical process and teaching/learning principles to provide subject/family education and develop education tools/materials.
6. Coordinates/collects requested data for sponsor review during site visits. Assists study monitor(s) in chart and case report form review. Maintains files and study documentation according to institutional and regulatory standards.
7. Provides oversight for the orientation/precepting program; leads training and monitors process of preceptors. Promotes Mentoring relationships and leads community teaching. Leads education of subjects and families.
8. Leads performance improvement and research activities .
9. Performs other duties as assigned.
Clinical Research Professional II • Little Rock, AR, US
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