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Regulatory Affairs Specialist
3 months ago
Description Regulatory Affairs Specialist - Clinical Research - Swedish Cherry Hill Schedule: (Full-time; Day shift) 8:00 AM to 5:00 PM PST (Mondays to Fridays) Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research. This includes preparation of all submissions to the IRB to assure the protection of human subjects in research; FDA-required submissions which may include investigator 1572 forms, investigational new drug applications, device submissions such as Emergency use, HDE, Safety Reports, and other documents that may be required by a regulatory agency or the institution. Leads the work of Research Assistants on a task-basis if applicable. Provides on-the-job training, sets priorities and schedules workflow required to support project objectives. Required Qualifications: Bachelor's Degree preferably in science, healthcare, or other related field or significant experience in research coordination or regulatory work may be substituted for educational requirements. 2 years experience in healthcare, research or clinical setting with regulatory compliance familiarity. About Providence At Providence, our strength lies in Our Promise of “Know me, care for me, ease my way.” Working at our family of organizations means that regardless of your role, we’ll walk alongside you in your career, supporting you so you can support others. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. Providence is proud to be an Equal Opportunity Employer . We are committed to the principle that every workforce member has the right to work in surroundings that are free from all forms of unlawful discrimination and harassment. Requisition ID: 289831 Company: Swedish Jobs Job Category: Research Job Function: Clinical Support Job Schedule: Full time Job Shift: Day Career Track: Clinical Professional Department: 3909 SRE Neuroscience Research Address: WA Seattle 550 16th Ave Work Location: Swedish Cherry Hill 550 16th-Seattle Pay Range: $34.38 - $54.42 #J-18808-Ljbffr
