Swedish Health Services Federal Regulatory Affairs Coordinator - Swedish Cancer Institute in Seattle, Washington
The Swedish Cancer Institute is calling a Federal Regulatory Affairs Coordinator (1.0 FTE, Days) in Seattle, WA.
The 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.
In this position you will have the following responsibilities:
Prepare applications for initial submission to Institutional Review Board (IRB) for review including: completes required application forms, creates consent forms to meet SMC standards, collects appropriate supporting documents (i.e. IND information, questionnaires, letters, investigational drug brochures, 1571’s, etc.) and responds to Institutional Review Office and Institutional Review Board requests
Prepare applications for ongoing annual review by the IRB including: completes required annual report form, updates consent form, collects 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, updating consent forms, etc.
Submit Safety Adverse Event (SAE) Reports to IRB as required by sponsors and, if appropriate, make changes to the consent form to reflect new information about adverse events; provide support to staff in completing local SAE Reports for submission to study sponsors and the IRB
Prepare federal reporting documents including, but not limited to: PHS 310 forms, FDA 1571 and 1572 forms
Required qualifications for this position includes:
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
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
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 Main Bldg (WA145) 747 Broadway Seattle, 98122
Req ID: 322642