Swedish Health Services - Seattle, WA
posted 3 months ago
The Senior Clinical Research Analyst in Oncology Regulatory Affairs plays a crucial role in ensuring compliance with federal, state, and local regulations as well as institutional requirements related to clinical research. This position involves the preparation, facilitation, coordination, and submission of essential documents required for the conduct of research. Key responsibilities include preparing submissions to the Institutional Review Board (IRB) to protect human subjects involved in research, as well as FDA-required submissions such as investigator 1572 forms, investigational new drug applications, and device submissions including Emergency Use and Humanitarian Device Exemptions (HDE). The analyst will also be responsible for leading the work of Research Assistants on a task-basis, providing education and on-the-job training, setting priorities, and scheduling workflow to support project objectives. At Providence, caregivers are not just valued; they are considered invaluable. The organization emphasizes a culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. The role is designed to empower employees, ensuring that their voices are heard and that they are supported in their careers. The position is based at Swedish First Hill in Seattle, WA, and is part of a larger network that includes over 50 hospitals and 1,000 clinics across multiple states. Providence is committed to serving the poor and vulnerable, continuing a tradition of over 100 years in healthcare. The Senior Clinical Research Analyst will work within a team dedicated to improving the wellbeing of communities by expanding access to quality healthcare. This role is integral to advancing best practices in clinical research and regulatory affairs, ensuring that all research activities align with the highest standards of ethical and regulatory compliance.