Regulatory Affairs Specialist

5 months ago


Seattle, United States Providence Full time

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 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 of improving the health and wellbeing of each patient we serve.

Accepting a new position at another facility that is part of the Providence family of organizations may change your current benefits. Changes in benefits, including paid time-off, happen for various reasons. These reasons can include changes of Legal Employer, FTE, Union, location, time-off plan policies, availability of health and welfare benefit plan offerings, and other various reasons.



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