Clinical Regulatory Compliance Specialist

2 weeks ago

Seattle, Washington, United States Swedish Full time

Position Overview

Regulatory Affairs Specialist - Clinical Research

Schedule: Full-time; Day shift 8:00 AM to 5:00 PM PST (Monday to Friday)

The role involves the preparation, facilitation, coordination, and submission of necessary documentation as mandated by federal, state, and local regulations, along with institutional requirements pertinent to research activities. This encompasses the formulation of all submissions to the Institutional Review Board (IRB) to ensure the safeguarding of human subjects involved in research; submissions required by the FDA, which may include investigator 1572 forms, investigational new drug applications, and device submissions such as Emergency Use Authorizations, Humanitarian Device Exemptions, Safety Reports, and other documents as required by regulatory agencies or the institution.

The specialist will oversee the tasks of Research Assistants as needed, providing on-the-job training, establishing priorities, and scheduling workflows essential to meet project objectives.

Essential Qualifications:

  • Bachelor's Degree in a relevant field such as science or healthcare, or substantial experience in research coordination or regulatory functions may be considered in lieu of educational qualifications.
  • A minimum of 2 years of experience in a healthcare, research, or clinical environment with familiarity in regulatory compliance.

Why Work with Us?

We offer a comprehensive benefits package designed to support your health, professional growth, and financial security. Our commitment is to ensure you can focus on our mission of enhancing the health and well-being of each patient we serve.

About Our Organization

Our strength is rooted in our promise to "Know me, care for me, ease my way." Working within our organization means that every role contributes to a collective mission of support and care. We provide competitive benefits and foster an inclusive environment where diversity is celebrated, and every voice is valued. Our extensive network includes numerous hospitals, clinics, and a wide range of health and social services across multiple states.

Commitment to Diversity and Inclusion

We are dedicated to creating a workforce that reflects the diversity of the communities we serve. Our recruitment practices are designed to attract the best talent from all backgrounds, ensuring an inclusive workplace where every individual is respected and valued.

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