Federal Regulatory Affairs Coordinator - Swedish Cancer Institute

Company: Pacific Medical Centers
Location: Seattle
Posted on: November 22, 2021

Job 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.

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 familiarityAbout 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.

Keywords: Pacific Medical Centers, Seattle , Federal Regulatory Affairs Coordinator - Swedish Cancer Institute, Other , Seattle, Washington