Regulatory Affairs Coordinator

You Belong Here.At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mission - partnering and healing for a healthy future - and dedicated to the health and well-being of the communities we serve.FTE: 0.01, Shift: Day, Schedule: Variable - *Must reside in the state of WA, to work remotely*Position SummaryThe Regulatory Affairs Coordinator is responsible for the preparation, facilitation, coordination and submission of 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 submission which may include investigator 1572 forms, investigational new drug applications, and device submissions such as Emergency use, HDE, safety reports and other documents that may be required by the regulatory agency or the institution. Provide education, on-the-job training, sets priorities and schedules workflow required to support project objectives. Duties require use of independent interpretation and application of relevant Federal and State laws and regulations and institutional policies and guidelines. This requires considerable exercise of independent judgment related to situations of a sensitive, confidential and scientific nature.Requirements• Bachelor’s degree; Minimum four (4) additional years of regulatory experience in related field may be substituted for degree• Current Washington state driver’s license• Minimum two (2) years of regulatory experience in research setting• Proof of a safe driving record (which meets established MultiCare Standards) obtained by a motor vehicle report from the appropriate stateOur ValuesAs a MultiCare employee, we'll rely on you to reflect our core values of Respect, Integrity, Stewardship, Excellence, Collaboration and Kindness. Our values serve as our guiding principles and impact every aspect of our organization, including how we provide patient care and what we expect from each other.Why MultiCare?• Belonging: We work to create a true sense of belonging for all our caregivers• Mission-driven: We are dedicated to our mission of partnering for healing and a healthy future and the patients and communities we serve• Market leadership: Washington state's largest community-based, locally governed health system• Employee-centric: Named Forbes “America’s Best Employers by State” in 2023• Technology: "Most Wired" health care system 15 years in a row• Leading research: MultiCare Institute for Research & Innovation, 40 years of ground-breaking, clinical and health services research in our communities• Lifestyle: Live and work in the Pacific Northwest - offering breathtaking water, mountains and forest at every turnPay and Benefit ExpectationsWe provide a comprehensive benefits package, including competitive salary, medical, dental and retirement benefits and paid time off. As required by various pay transparency laws, we share a competitive range of compensation for candidates hired into each position. The pay scale is $27.86 - $40.08 USD. However, pay is influenced by factors specific to applicants, including but not limited to: skill set, level of experience, and certification(s) and/or education. If this position is associated with a union contract, pay will be reflective of the appropriate step on the pay scale to which the applicant’s years of experience align.Associated benefit information can be viewed here.