Job Information
Providence St. Joseph Health Regulatory Affairs Specialist - Clinical Research in Seattle, Washington
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. Providence caregivers are not simply valued - they're invaluable. Join our team at Swedish Research and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them. 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 Why Join Providence? Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve. Apply Today! Applicants that meet qualifications will receive a text with some additional questions from our HireVue system. 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. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. 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. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable. The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits. About the Team Providence Swedish is the largest not-for-profit health care system in the greater Puget Sound area. It is comprised of eight hospital campuses (Ballard, Edmonds, Everett, Centralia, Cherry Hill (Seattle), First Hill (Seattle), Issaquah and Olympia); emergency rooms and specialty centers in Redmond (East King County) and the Mill Creek area in Everett; and Providence Swedish Medical Group, a network of 190+ primary care and specialty care locations throughout the Puget Sound. Whether through physician clin