Clinical Research Analyst - Oncology Regulatory Affairs

$71,510 - $113,194/Yr

Providence At Swedish Edmonds - Seattle, WA

Full-time - Mid Level

Seattle, WA

10,001+ employees

Ambulatory Health Care Services

About the position

The Clinical Research Analyst - Oncology Regulatory Affairs position at Swedish First Hill is a full-time role focused on the preparation, facilitation, coordination, and submission of documentation required by federal, state, and local regulations, as well as institutional requirements related to the conduct of research. This role is critical in ensuring compliance with regulations that protect human subjects involved in research. The analyst will be responsible for preparing all submissions to the Institutional Review Board (IRB) and ensuring that all necessary documentation is submitted to regulatory agencies, including the FDA. This may involve completing investigator 1572 forms, investigational new drug applications, and device submissions such as Emergency Use Authorizations and Safety Reports. In addition to regulatory submissions, the Clinical Research Analyst will lead the work of Research Assistants on a task-basis, providing on-the-job training and setting priorities to ensure that project objectives are met efficiently. The position requires a strong understanding of regulatory compliance and the ability to navigate complex documentation processes. The successful candidate will thrive in a collaborative environment that values patient-focused care and mutual respect among team members. At Providence, caregivers are seen as invaluable, and the organization is committed to empowering its employees to inspire and retain the best talent in the healthcare field. Working at Providence means being part of a comprehensive healthcare organization that serves a diverse population across multiple states. The organization is dedicated to improving the health and wellbeing of each patient served, and the Clinical Research Analyst will play a vital role in this mission by ensuring that all research activities comply with the highest standards of regulatory oversight. The position offers opportunities for professional growth and advancement within a supportive and inclusive workplace culture.

Responsibilities

• Prepare and submit documentation required by federal, state, and local regulations and institutional requirements for research.
• Coordinate and facilitate submissions to the IRB to protect human subjects in research.
• Complete FDA-required submissions including investigator 1572 forms and investigational new drug applications.
• Lead the work of Research Assistants on a task-basis, providing guidance and support.
• Provide on-the-job training and set priorities for workflow to support project objectives.

Requirements

• Bachelor's Degree in science, healthcare, or a related field.
• 2 years of experience in healthcare, research, or clinical settings with familiarity in regulatory compliance.
• Significant experience in research coordination or regulatory work may substitute for educational requirements.

Nice-to-haves

• Experience in oncology research or regulatory affairs is preferred.
• Strong organizational and communication skills.

Benefits

• Paid parental leave
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• On-the-job training
• Vision insurance
• 401(k) matching
• Life insurance