Clinical Research Compliance Officer
2 weeks ago
Position Overview
Clinical Regulatory Compliance Specialist
Schedule: Full-time; Day shift 8:00 AM to 5:00 PM PST (Monday to Friday)
The Clinical Regulatory Compliance Specialist is responsible for preparing, coordinating, and submitting essential documentation in accordance with federal, state, and local regulations as well as institutional policies related to research activities. This role involves the meticulous preparation of submissions to the Institutional Review Board (IRB) to ensure the safeguarding of human subjects involved in research. Additionally, the specialist will handle FDA-required submissions, which may encompass investigator 1572 forms, investigational new drug applications, and device submissions, including Emergency Use Authorizations, Humanitarian Device Exemptions, Safety Reports, and other regulatory documents as mandated by relevant authorities.
This position may involve leading the efforts of Research Assistants on a task-specific basis, providing necessary training, establishing priorities, and scheduling workflows to meet project goals effectively.
Qualifications Required:
- Bachelor's Degree in a relevant field such as science or healthcare, or equivalent experience in research coordination or regulatory affairs.
- A minimum of 2 years of experience in a healthcare, research, or clinical environment with a solid understanding of regulatory compliance.
Why Choose Swedish Medical Center?
At Swedish Medical Center, we offer an exceptional benefits package designed to support the well-being of you and your family, enabling you to focus on our mission of enhancing the health and wellness of every patient we serve.
About Swedish Medical Center
As a leading not-for-profit healthcare system, Swedish Medical Center is dedicated to providing comprehensive care across various facilities. Our commitment to diversity and inclusion is central to our mission, ensuring that every team member works in an environment free from discrimination and harassment. We believe that a diverse workforce strengthens our organization and enhances the care we provide.
Benefits and Rewards
We recognize and celebrate the contributions of our caregivers, offering a range of benefits that include health care coverage, retirement plans, and well-being resources. Our mission is clear: to improve the health and well-being of each patient we serve.
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