Research Assistant

The Research Assistant is to provide support to internal and external study contacts in the conduct of all study activities related to clinical trial(s) as well as to develop subject matter expertise to identify trends in all aspects of the study to ensure all standards are met, the clinical trial operates efficiently, and to ensure data quality. Job duties include:
1. Create and test data reports, databases, edit checks, case report forms (CRFs), and related programs, technology, and support tools for efficient collection, analysis, and reporting
2. Troubleshooting and problem-solving issues with study systems, reports, data queries
3. Support Research Coordinator/Program Manager to oversee the management and reporting of data
4. Coordinate logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies
5. Request and review reports from the Statistics and/or ICT Department(s) to maintain data integrity of the study
6. Develop study support tools, reports, and trackers (i.e. manuals, instructional documents)
7. Maintain and manage access to study database and systems for all study personnel
8. Maintain ongoing communication with sites regarding all study related materials and issues to ensure all materials are up to date.
9. Compile and review documentation required for Good Clinical Practice and/or as required from the study sponsor
10. Coordinate drug supply and demand with study sponsor and IP manufacturer, packager, distributor to prevent shortages and overages
11. Perform activities related to major protocol deviations and data transfers
12. Provide training to PHRI and external study staff
13. Implement protocol amendments in consultation with the Research Coordinator/Program Manager
14. Review IP-related information provided on study CRFs. Apply and resolve queries.
15. Provide user access to IP management systems (IVRS/IWRS)
16. Other duties as assigned.