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Position Summary: The Regulatory Affairs Specialist 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, safety reports and other documents that may be required by the regulatory agency or the institution. 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 some exercise of independent judgment related to situations of a sensitive, confidential and scientific nature.
Minimum Requirements: One year research and/or regulatory experience in research setting
Education/Licenses/Certifications: Associates degree preferred Employee must provide automobile for use in their work and the employee must be able to comply with MHS Policy on Vehicle Use, Employee Owned. Policy available on request
Position Type: Full-Time Regular Full Time Employee: YesPrimary Shift: Day Work Schedule: day
MultiCare is a not-for-profit health care organization with more than 20,000 team members, including employees, providers and volunteers. MultiCare has been caring for our community for well over a century, since the founding of Tacoma’s first hospital and today is the largest community-based, locally governed system of health in the state of Washington, serving communities across Washington and Northern Idaho.
MultiCare’s comprehensive system of health includes numerous primary care, urgent care and specialty services — including Mary Bridge Children’s Hospital & Health Network; MultiCare Indigo Urgent Care; Pulse Heart Institute; MultiCare Medical Associates, affiliated physicians; MultiCare Rockwood Clinic, the largest multispecialty clinic in the Inland Northwest region; and MultiCare Connected Care, our Accountable Care Organization.
Eleven hospitals complete the organization: Allenmore Hospital, Auburn Medical Center, Capital Medical Center, Covington Medical Center, Deaconess Hospital, Good Samaritan Hospital, Mary Bridge Children’s Hospital — the Puget Sound region’s only children’s hospital and state-designated Level II Pediatric Trauma Center for Western Washingt...on — Navos Behavioral Health Hospital, Valley Hospital, Tacoma General Hospital — which is home to the South Puget Sound region’s only Level IV Neonatal Intensive Care Unit — and Wellfound Behavioral Health Hospital.
Our core values of Respect, Integrity, Stewardship, Excellence, Collaboration and Kindness, 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.
MultiCare is also proud of our commitment to workforce diversity and culturally competent care. This commitment is led by our CEO and supported through employee education and community outreach.