Diversity Jobs

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Job Information

Swedish Health Services Federal Regulatory Affairs Coordinator - Tumor Institute Research in Seattle, Washington

Description:

Federal Regulatory Affairs Coordinator

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.

Qualifications:

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

  • Two (2) years of experience in healthcare, research or clinical setting with regulatory compliance familiarity

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.

About the Swedish Center for Research and Innovation (SCRI).

SCRI supports and administers research activities throughout the six Swedish campus locations. SCRI is one of the leading clinical trial sites in the western United States, and at any given time, there are more than 600 research studies being conducted by Swedish-affiliated clinicians and other investigators. In addition to participating in major federally funded programs Swedish physicians are involved in research studies of new treatment approaches for everything from Coronary-Artery disease to Cancer to Multiple Sclerosis. To support this work, Swedish employs numerous research staff including coordinators, scientists, and research nurses. Below are a few highlights of our research.

Through our centralized oversight mechanism we support the core research functions of study coordination, financial oversight, risk management, federal grant administration (pre- and post-award),contract negotiation, feasibility and ethics review, clinical trial tracking and billing integration, regulatory compliance, investigator development and training.

We offer a full comprehensive range of benefits — see our website for details — https://caregiver.ehr.com

We offer comprehensive, best-in-class benefits to our caregivers. For more information, visit

https://swedish.jobs/why-swedish/#benefits-rewards

Our Mission

Our Mission is to improve the health and well-being of each person we serve.

Our Vision is Health for a Better World.

About Us

Swedish is the largest not-for-profit health care system in the greater Seattle area. It is comprised of five hospital campuses (First Hill, Cherry Hill, Ballard, Edmonds and Issaquah); emergency rooms and specialty center in Redmond (East King County) and the Mill Creek area in Everett; and Swedish Medical Group, a network of more than 128 primary care and specialty care locations throughout the greater Puget Sound area. Swedish employs nearly 13,000 caregivers (all employees), including nearly 1,400 providers. Whether through physician clinics, education, research and innovation or other outreach, we're committed to caring for the people in our region and beyond. Swedish is proud to be an Equal Opportunity Employer Swedish does not discriminate on the basis of race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.

Schedule: Full-time

Shift: Day

Job Category: Research

Location: Washington-Seattle

Work Locations: First Hill Main Bldg (WA145) 747 Broadway Seattle, 98122

Req ID: 356840

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