at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 50385
Department: MED-Clinical Trials Unit
Salary/Grade: NEX/11
Job Summary:
Under the direction of the Research Manager, the position will support the Institutional Review board (IRB) regulatory submission process for IRB continuing reviews , revisions/amendments, subject recruitment materials and safety reports (UPIRSOs) being processed through the BCVI Clinical Trials Unit. The submission process includes completion of submission process in the eIRB system. This position will serve as a contact liaison for regulatory matters among the research staff and Principal Investigators, sponsoring agencies and the IRB.
Specific Responsibilities:
- Assists in the preparation and tracking of IRB submissions including continuing reviews, revisions/amendments, subject recruitment materials and safety reports (UPIRSO) for BCVI CTU research studies. Completes IRB requests for modifications as needed. Maintains an open dialog with supervisor regarding the IRB process and project modifications.
- Works as a liaison between research staff and the IRB. Serves as contact between sponsor, PI, project coordinators and IRB. Communicates with collaborating faculty both inside and outside the University. Maintains an open dialog with supervisor regarding project modifications and communications.
- Prepares, circulates and obtains signatures on regulatory documents for new and on- going research projects. Files and maintains study related paperwork. Submits regulatory paperwork to sponsoring agencies (i.e. 1572, investigator CVs, financial disclosure forms).
- Maintain regulatory binders and documentation in collaboration with the research staff and study monitors to ensure studies are in compliance with applicable regulations. .
- Participates and assists with routine monitoring visits and study close-out visits ensuring regulatory documents are accounted for. Collaborates with research staff to coordinate monitoring visits.
- Sends study related documents to storage and maintain the filing systems.
- Supports CTU office operations
Miscellaneous
Performs other duties as assigned.
