The Swedish Cancer Institute is looking for a Federal Regulatory Affairs Coordinator (1.0 FTE, Days) at Swedish First Hill 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.
In this position you will:
Prepare all submissions to the Internal Review Board (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.
Provide on-the-job training, set priorities and schedule workflow required to support project objectives.
Serve as liaison between sponsors, researchers, staff, and study coordinators.
Coordinate and negotiate with commercial study sponsors with regards to consent form language.
Required qualifications for this position include:
Bachelor's degree, preferably in science, healthcare, or other related field. Significant experience in research coordination or regulatory work may be substituted for educational requirements
Minimum of two years of experience in healthcare, research or clinical setting with regulatory compliance familiarity
Working knowledge of computers, standard office software packages (Word, Excel, Access, Power Point, etc.), standard office equipment (photocopiers, facsimiles, telephones, pagers, etc.)
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.
Swedish Health Services