Lead Clinical Research Analyst

2 weeks ago


Seattle, Washington, United States Providence Health & Service Full time
Job Overview

Senior Clinical Research Analyst - Oncology Regulatory Affairs (Full Time, Day Shift)

As a Senior Clinical Research Analyst, you will be responsible for the preparation, facilitation, coordination, and submission of essential documents mandated by federal, state, and local regulations, as well as institutional requirements concerning research activities. This role involves the meticulous preparation of all submissions to the Institutional Review Board (IRB) to ensure the safeguarding of human subjects involved in research. Additionally, you will handle FDA-required submissions, which may encompass investigator 1572 forms, investigational new drug applications, device submissions including Emergency use, Humanitarian Device Exemptions (HDE), Safety Reports, and other documents as necessitated by regulatory agencies or the institution.

In this position, you will also lead the efforts of Research Assistants on a task-specific basis, providing education and on-the-job training. You will be responsible for establishing priorities and scheduling workflows to meet project objectives effectively.

Essential Qualifications:
  • Bachelor's Degree or equivalent experience, with five or more years in clinical research and regulatory affairs accepted in lieu of the degree requirement.
  • A minimum of 5 years of experience in a healthcare, research, or clinical environment.
Why Choose Providence?

At Providence, we offer a comprehensive benefits package designed to support you and your family in maintaining wellness, advancing professionally, and achieving financial stability. We prioritize your well-being, allowing you to focus on our mission of enhancing the health and well-being of every patient we serve.

About Providence Health & Services

Our organization is built on the foundation of our commitment to "Know me, care for me, ease my way." Working within our network means that regardless of your role, we will support you in your career, enabling you to provide exceptional care to others. We pride ourselves on offering top-tier benefits and fostering an inclusive workplace where diversity is celebrated, and every individual is valued, heard, and respected. Our dedicated team of over 120,000 caregivers serves in more than 50 hospitals and over 1,000 clinics, delivering a full spectrum of health and social services across multiple states. As a comprehensive healthcare organization, we are committed to serving a diverse population, advancing best practices, and continuing our long-standing tradition of supporting the underserved.

Providence is an Equal Opportunity Employer, dedicated to ensuring that every member of our workforce has the right to work in an environment free from discrimination and harassment based on race, color, gender, disability, veteran status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by law. We believe that diversity strengthens our organization, and we are committed to fostering an inclusive workforce that promotes equal opportunities for all.

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