Clinical Research Regulatory Analyst — IRB & FDA Submissions

Providence; Seattle (WA); On-site; USD 70,000 - 95,000; Full time

Job summary

You will manage IRB submissions to protect human subjects, assist with FDA filings as needed, and lead Research Assistants on task-based work while setting priorities and timelines to support project objectives.

Qualifications

• 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 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.
• 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.

Skills

Regulatory compliance

IRB submissions

Education

Bachelor's Degree in science, healthcare, pharmacy, or related field

Job description

You will manage IRB submissions to protect human subjects, assist with FDA filings as needed, and lead Research Assistants on task-based work while setting priorities and timelines to support project objectives.