Associate Clinical Research Analyst - Tumor Research Institute

Providence•Seattle, WA

About The Position

Prepares, facilitates, coordinates, and submits documentation required by federal, state, and local regulations and institutional requirements for conducting research. This includes preparing submissions to the Institutional Review Board (IRB) to protect human subjects, as well as FDA-required submissions, which may include investigator Form 1572 documents, investigational new drug applications, device submissions such as Emergency Use and HDE, safety reports, and other documents required by regulatory agencies or the institution. Leads Research Assistants on a task basis when applicable. Provides on-the-job training, sets priorities, and schedules workflow to support project objectives. The role is with Swedish Research at Providence, whose culture emphasizes patient-focused, whole-person care, understanding, commitment, and mutual respect.

Requirements

Bachelor's degree, preferably in science, healthcare, pharmacy, or another related field; significant experience in research coordination or regulatory work may substitute for the educational requirement.
Two years of experience in healthcare, research, or a clinical setting, with familiarity with regulatory compliance.

Responsibilities

Prepare, facilitate, coordinate, and submit research documentation required by federal, state, and local regulations and institutional requirements.
Prepare IRB submissions to support the protection of human subjects in research.
Prepare FDA-required submissions, potentially including investigator Form 1572 documents, investigational new drug applications, device submissions such as Emergency Use and HDE, and safety reports.
Prepare other documents required by regulatory agencies or the institution.
Lead the work of Research Assistants on a task basis when applicable.
Provide on-the-job training.
Set priorities and schedule workflow to support project objectives.