Swedish Medical Center is looking for a Regulatory Affairs Specialist Senior (1.0 FTE, Day shift) to work in Clinical Trials Research at Swedish First Hill in Seattle, WA.
Prepare, facilitate and coordinate, and submit documents 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. Lead the work of Research Assistants on a task-basis, if applicable. Provide education, on-the-job training, set priorities and schedule workflow required to support project objectives. Duties require the use of judgment and 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.
In this position you will:
- Coordinate and/or complete applications for initial submission to the Institutional Review Board (IRB) for review including: assist with protocol development activities, complete required application forms, create consent forms to meet SMC and sponsor standards, collect appropriate supporting documents (i.e. IND information, questionnaires, letters, investigational drug brochures, 1571’s, 1572, HDE, IND compassionate, expanded access, etc.) and respond to Institutional Review Office and Institutional Review Board requests.
- Prepare applications for ongoing annual review by the IRB including: completion of required annual report form, updated consent form, collection of information regarding results of study or findings to date, adverse events experienced, etc.
- Prepare applications for protocol modification for submission to the IRB including: complete Protocol Modification Form(s); review and identify changes to be reviewed; update consent forms, etc.
- Analyze and submit Unanticipated Problems (i.e. Adverse Events (AEs), Serious Adverse Events (SAEs) and Deviation reports to the IRB as required by sponsors and, if appropriate, make changes to the consent form to reflect new information about adverse events; provide support to internal/external staff in completing AE or SAE Reports for submission to study sponsors and the IRB.
- Conduct education and training of coordinators, physicians, and all research staff regarding ICH, GCP, CFR’s and local P&P’s related to research. Serve as information specialist and resource for regulatory, ethical and methodological questions and issues from staff, coordinators, and internal/external researchers. Coordinate, develop and/or conduct the education of the research team. Provide one-on-one coaching as needed to researchers.
- Bachelor's Degree Or equivalent educ/experience - Five or more years of education or experience in clinical research and regulatory affairs may be accepted in lieu of the degree requirement.
- 5 years Experience in healthcare, research or clinical setting.
About the First Hill Campus
The 697-bed tertiary-care center on the Swedish/First Hill campus is the flagship of the Swedish health-care system. Swedish/First Hill has one of the most active and advanced birthing programs in Washington state and houses a Level III neonatal intensive-care unit. More surgeries are performed each year at Swedish/First Hill than at any other facility in the region; volumes include more total joint replacements than any other medical center in the state.
We offer comprehensive, best-in-class benefits to our caregivers. For more information, visit
Our Mission is to improve the health and well-being of each person we serve.
Our Vision is Health for a Better World.
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.
Job Category: Research
Work Locations: First Hill Heath Bldg (WA204) 801 Broadway Seattle, 98122
Req ID: 304382