Clinical Regulatory Submissions Specialist

Providence Swedish Medical Center; Seattle (WA); Hybrid; USD 43,000 - 66,000; Full time

Benefits offered by this job

401(k) match

Health insurance

Life insurance

Disability insurance

Paid time off

Parental leave

Well-being resources

Job summary

Providence Swedish Medical Center seeks a Regulatory Coordinator to prepare and submit regulatory documents for research, ensuring protection of human subjects. You will coordinate FDA and IRB submissions and guide Research Assistants in prioritizing workflows.

The role involves training, setting priorities, and maintaining compliance across federal and local requirements, with a hybrid work arrangement and a comprehensive benefits package.

Qualifications

• Bachelor’s degree in science/healthcare/pharmacy or related field; or substitute with significant regulatory experience.
• 2 years experience in healthcare, research, or clinical setting with regulatory compliance familiarity.
• Experience coordinating IRB submissions or regulatory documentation is a plus.

Responsibilities

• Prepare, facilitate, coordinate, and submit documentation required by regulations and institutional requirements for research.
• Lead Research Assistants on a task basis; provide on-the-job training; set priorities and schedules to support project objectives.
• Support IRB submissions, FDA-related submissions, and other regulatory documents as required.

Skills

Regulatory compliance

Research coordination

Healthcare experience

Education

Bachelor's degree in science/healthcare/pharmacy or related field

Job description

Providence Swedish Medical Center seeks a Regulatory Coordinator to prepare and submit regulatory documents for research, ensuring protection of human subjects. You will coordinate FDA and IRB submissions and guide Research Assistants in prioritizing workflows.

The role involves training, setting priorities, and maintaining compliance across federal and local requirements, with a hybrid work arrangement and a comprehensive benefits package.