TI Sr Clinical Research Associate in Portland, Oregon | Careers at Portland, OR (Waterfront)
The Senior Coordinator oversees all regulatory activities for each study in the program. This includes the following:  IRB Protocol Management and Development – In collaboration leadership and based on sponsor protocol, develop and submit new IRB protocols for review. – Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated – Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments and continuing reviews are submitted timely when adjustments are needed. – Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes, and address regulatory gaps with IRB protocols. Study Documentation – Monitor and ensure documentation storage meets FDA, institutional and sponsor guidelines. – Oversight and maintenance of all regulatory binders fo
