Associate Clinical Research Analyst - Tumor Institute

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.

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• 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

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