Clinical Research Coordinator III

About the role

The Senior Clinical Research Coordinator (CRC III) is responsible for day-to-day management of oncology clinical trials including complex early phase treatment trials. The position will oversee all subject-level study workflows including screening patients for eligibility, coordinating and tracking patient visits and procedures, and creating and maintaining research documentation.

Responsibilities

• Maintain comprehensive knowledge of assigned research protocols, with particular emphasis on data collection requirements, eligibility criteria, and long-term follow-up expectations.
• Independently collect, abstract, analyze, and interpret clinical trial data from pre-study medical history through active participation and long-term follow-up in accordance with protocol and regulatory requirements.
• Perform detailed eligibility assessments and lead patient screening and enrollment activities for assigned clinical trials.
• Coincide and collaborate across Fred Hutch, Seattle Children’s, and UW Medicine clinical, ancillary, and administrative departments to ensure accurate and timely data capture and reporting.
• Proactively track and manage the status of potential, enrolled, active, and completed clinical trial participants.
• Coordinate and oversee long-term follow-up activities, including data collection with clinical trial participants, internal providers, and external/community physicians.
• Design, develop, and maintain study-specific data collection tools, source documentation templates, and completion guidelines.
• Partner with data management and data coordinators for assigned research projects to ensure accuracy, completeness, and compliance with protocol and regulatory standards.
• Serve as the primary point of contact for sponsor monitoring visits, audits, and internal quality assurance reviews related to data management and protocol compliance.
• Ensure readiness for and actively support sponsor, investigator-initiated, and institutional monitoring visits; address findings and implement corrective actions as needed.
• Act as a subject matter expert and liaison to investigators, clinicians, research staff, and external stakeholders regarding protocol procedures, data requirements, and study workflows.
• Lead or contribute to special projects related to data management, analysis, reporting, and presentation of study outcomes.
• Support programmatic goals by contributing to process improvement initiatives, SOP development, and best practices in clinical research operations.
• Coordinate with Regulatory staff for assigned studies, including amendments, continuing reviews, reportable events, and safety reporting.
• Provide training, mentorship, and ongoing guidance to CRC I/II staff and others as assigned; serve as a resource for complex studies.
• Oversee data management activities for assigned research projects to ensure accuracy, completeness, and compliance with protocol and regulatory standards.

Qualifications

• Bachelor’s Degree in scientific/medical field or equivalent combination of education and experience.
• Six or more years of experience in medical records, cancer registry, clinical study coordination or related field.
• Clinical research-related professional certification preferred.
• Experience managing oncology treatment trials preferred.
• Experience working in an academic medical center preferred.
• Experience working in Epic and a clinical trial management system (CTMS) preferred.
• Knowledge of FDA regulations, GCP guidelines, and other applicable regulations.
• Ability to work independently and prioritize work in a dynamic environment.
• Collaborative and skilled working across multidisciplinary teams including clinical teams.
• Resourceful and able to solve problems, yet seek guidance when needed.
• Comfortable working in clinic setting and interacting with patients.
• Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs).
• Exceptional interpersonal skills both in-person and on telephone calls.
• Strong written and verbal communication skills.