About The Position

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. Providence Swedish caregivers are not simply valued – they’re invaluable. Join our team at Swedish Research and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them.

Requirements

  • Bachelor's degree preferably in science, healthcare, pharmacy, or other related field, or significant experience in research coordination or regulatory work may be substituted for educational requirements
  • 2 years of experience in healthcare, research or clinical setting with regulatory compliance familiarity

Responsibilities

  • Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research.
  • Prepares all submissions to the IRB to assure the protection of human subjects in research.
  • Prepares 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.

Benefits

  • Best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally, and achieving financial security.
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