Associate Clinical Research Analyst - Tumor Institute

Providence Swedish is a not-for-profit healthcare organization with a research and clinical care focus. The Associate Clinical Research Analyst supports tumor research by preparing and submitting regulatory documentation, coordinating IRB and FDA requirements, and facilitating research workflows. The role also provides task-based leadership and training to Research Assistants when applicable.

Responsibilities

• 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

Benefits

• Retirement 401(k) Savings Plan with employer matching
• Health care benefits (medical, dental, vision)
• Life insurance
• Disability insurance
• Paid parental leave
• Vacations
• Holidays
• Health issues
• Voluntary benefits
• Well-being resources
• Shift differentials may be available for this role
• Standby/on-call compensation may be available for this role
• Overtime may be available for this role
• Premiums may be available for this role
• Extra shift incentives may be available for this role
• Bonus opportunities may be available for this role

Company

• Western Washington health care delivery system and hospital network
• Seattle, Washington, USA
• https://blog.providenceswedish.jobs/
• Founded in 1908
• 10001+ employees

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 of experience in healthcare, research or clinical setting with regulatory compliance familiarity

Required skills

• Clinical Research Coordination, FDA Regulatory Submissions, Institutional Review Board (IRB) Submissions, Regulatory Compliance

Experience

• 2+ years