Clinical Research Regulatory Lead (Education & Compliance)

University of Washington Medical Center; Seattle (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

University of Washington Medical Center in Seattle is seeking a Research Coordinator 4 to oversee regulatory affairs and research compliance across the Ophthalmology department. The role collaborates with investigators, study teams, sponsors, and stakeholders to ensure adherence to GCP, IRB oversight, and FDA regulations.

Responsibilities include leading regulatory submissions, maintaining audit-ready TMFs, developing tools for trial operations, and serving as the primary liaison for regulatory

Responsibilities

• Coordinate regulatory and compliance activities for complex investigator-initiated and/or industry-sponsored clinical research studies.
• Maintain complete and audit-ready regulatory documentation, including TMFs and records within OnCore and other regulatory systems.
• Obtain and maintain IRB approvals, including initial submissions, continuing review, protocol modifications, amendments, and study closures.
• Serve as the primary regulatory liaison for investigators, study teams, sponsors, and oversight bodies.

Job description

University of Washington Medical Center in Seattle is seeking a Research Coordinator 4 to oversee regulatory affairs and research compliance across the Ophthalmology department. The role collaborates with investigators, study teams, sponsors, and stakeholders to ensure adherence to GCP, IRB oversight, and FDA regulations.

Responsibilities include leading regulatory submissions, maintaining audit-ready TMFs, developing tools for trial operations, and serving as the primary liaison for regulatory