Federal Regulatory Affairs Coordinator - Swedish Cancer Institute

Description:

The Swedish Cancer Institute is looking for a Federal Regulatory Affairs Coordinator (1.0 FTE, Day Shift) to work at Swedish Research in Seattle, WA.

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, create consent forms to meet SMC standards, collect appropriate supporting documents (i.e. IND information, questionnaires, letters, investigational drug brochures, 1571’s, etc.) and respond to Institutional Review Office and Institutional Review Board requests.
• Prepare applications for ongoing annual review by the IRB including: complete required annual report form, update consent form, collect information regarding result 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.

Qualifications:

Required qualifications for this position include:

• 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 experience in healthcare, research or clinical setting with regulatory compliance familiarity

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

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: 307120