Research Coordinator 4 (E S UAW Research) at UW in Seattle, WA

Job description

Job Description The Department of Ophthalmology has an outstanding opportunity for Research Coordinator 4 to join their team. OVERVIEW : Reporting to the Associate Director of Research, the Research Coordinator 4 serves as the subject matter expert on the full scope of clinical research education, management and compliance for the entire Department of Ophthalmology at the University of Washington. The Research Coordinator 4 with collaborate with the Associate Director of Research to oversee educational programs that span the entire scope of clinical research operations, including training, trial start-up, study management, regulatory compliance, financial operations, and billing practices. The Research Coordinator 4 provides strategic leadership, oversight, and operational management of regulatory affairs and research compliance activities supporting clinical research programs at the University of Washington (UW). This position ensures that all clinical research activities are conducted in accordance with federal, state, local, sponsor, and institutional requirements, including regulations governing human subjects research, FDA-regulated studies, Good Clinical Practice (GCP), and institutional review board (IRB) oversight. The Research Coordinator 4 serves as the department's subject matter expert in clinical research regulation, compliance, education, and operations, partnering with investigators, study teams, sponsors, and institutional stakeholders to ensure research excellence and regulatory compliance. The Research Coordinator 4 provides strategic leadership for regulatory affairs and research compliance programs, including regulatory submissions, compliance monitoring, personnel supervision, and corrective action initiatives supporting clinical research across the Department of Ophthalmology. RESPONSIBILITIES: Clinical Research Regulatory Management and Oversight (30%) • Independently coordinate and oversee regulatory and compliance activities for complex investigator-initiated and/or industry-sponsored clinical research studies, exercising professional judgment in interpreting institutional, federal, and sponsor requirements. • Manage regulatory submissions including: - Initial IRB applications - Continuing reviews - Modifications and amendments - Reportable events - Safety reports - Study closures • Maintain complete and audit-ready regulatory documentation, including TMFs and records within OnCore and other regulatory systems. • Develop and disseminate standardized tools, templates, and job aids to support all operational phases of clinical research from start-up to close-out. • Obtain and maintain IRB approvals, including initial submissions, continuing review, protocol modifications, amendments, and study closures. • Report and document safety issues (e.g. adverse events) to the applicable oversight body. • Prepare for and participate in sponsor audits and/or regulatory inspections, if applicable. • FDA Investigational New Drug and Device Exemption (IND/IDE) application support. • Serve as the primary regulatory liaison for investigators, study teams, sponsors, and oversight bodies. Research Compliance Program Management (30%) • Coordinate and support the development, implementation, and continuous improvement of research compliance processes and programs supporting clinical trials and human subjects research. • Develop, implement, and maintain research compliance programs supporting clinical trials and human subjects research. • Evaluate study activities for adherence to: - FDA regulations - OHRP requirements - HIPAA regulations - Good Clinical Practice (ICH-GCP) - University of Washington policies - Sponsor requirements • Track compliance metrics and prepare reports for departmental and institutional leadership. • Lead compliance monitoring, risk assessments, audits (sponsor, FDA, NIH, OHRP, institutional), and inspection-readiness activities; manage findings, CAPA plans, and reporting to ensure ongoing adherence