Regulatory Affairs Assistant

Facilitate document flow to ensure timely completion and distribution of study documents for all clinical trials at NEXT Oncology. Conduct feasibility questionnaires for proposed trials, set up Site Initiation Visits, and enter study-specific information into the internal FileMaker database. Maintain official regulatory files in the eDOCS system, distribute IRB approval documents within 24 hours, and manage access for staff and sponsors. Complete administrative tasks including answering phones, faxing, and preparing documents such as FDA 1572s and delegation logs. Maintain investigator CVs, medical licenses, and training documents for GCP and HRS compliance. Provide excellent customer service to internal and external visitors while attending Phase I meetings and Site Initiation Visits.