Clinical Research Coordinator II

Fred Hutch Cancer Center; Seattle (WA); On-site; USD 70,000 - 95,000; Full time

Job summary

The Fred Hutchinson Cancer Center in Seattle seeks a Clinical Research Coordinator II to coordinate interventional Phase I-III clinical trials and observational studies across disease programs. You will manage participant screening, enrollment, visit coordination, data collection, and study documentation.

Reporting to the Senior Manager/Manager of Clinical Trials Coordination, you will partner with investigators and study teams to ensure compliant protocol execution and continuity of research

Qualifications

• Coordinate daily operations of clinical studies in line with study protocols, regulatory and GCP guidelines.
• Develop and maintain tools for study implementation and onboarding to new assignments.
• Provide study-specific education and training to clinic staff, participants, and other stakeholders.
• Coordinate patient enrollment by reviewing medical records for eligibility and ensuring informed consent.
• Track and manage samples, lab tests, and study supplies as required by the protocol.

Responsibilities

• Coordinate patient enrollment and participation by reviewing study candidates' medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
• Schedule patient clinic visits and ongoing study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests, and other patient activities; may administer study questionnaires, perform non-clinical ECGs, and support investigational product accountability activities, including participant education, documentation, reconciliation, and pill counts for participant-managed study medications, as applicable.
• Provide temporary operational support during staffing vacancies, leaves of absence, enrollment surges, study startup activities, and other identified business needs to ensure continuity of research operations.
• Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples, and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
• Identify, track, and confirm billable activities for patients; work with internal partners to obtain and submit budget and billing information; may assist in reviewing patient charges to ensure billing compliance.
• Serve as a protocol liaison with clinical t

Job description

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality. At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. The Clinical Research Coordinator II is responsible for coordinating interventional Phase I-III clinical trials and observational Cancer Control studies while providing flexible support across disease programs and research teams. The position manages subject-level study activities including participant screening and enrollment, visit coordination, study documentation, data collection and reporting, and research specimen management. The coordinator collaborates with investigators, study teams, and Data Coordination staff within Clinical Research Support to ensure the successful execution of research studies and continuity of research operations. Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the coordinator will serve as part of the Clinical Trial Support Team, providing flexible clinical research coordination support across disease programs and care settings. This position may be deployed to support staffing coverage needs, enrollment growth, study startup activities, and other operational priorities while ensuring continuity of research operations. The coordinator is expected to rapidly integrate into new study teams and maintain high-quality study conduct in accordance with protocol, regulatory, and institutional requirements. This position is key to the smooth operation of clinical trials and advancing research efforts at Fred Hutch. At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

• Conduct daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy while providing flexible support across disease programs, research teams, and community sites based on organizational priorities.
• Develop and maintain tools for study implementation, including data collection tools, reference materials, and specific study orders; revise and utilize tools as necessary to support study continuity and efficient onboarding to new assignments.
• Provide study-specific education and training to clinic staff, participants, and other stakeholders to support accurate and compliant protocol implementation.
• Coordinate patient enrollment and participation by reviewing study candidates' medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
• Schedule patient clinic visits and ongoing study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests, and other patient activities; may administer study questionnaires, perform non-clinical ECGs, and support investigational product accountability activities, including participant education, documentation, reconciliation, and pill counts for participant-managed study medications, as applicable.
• Provide temporary operational support during staffing vacancies, leaves of absence, enrollment surges, study startup activities, and other identified business needs to ensure continuity of research operations.
• Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples, and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
• Identify, track, and confirm billable activities for patients; work with internal partners to obtain and submit budget and billing information; may assist in reviewing patient charges to ensure billing compliance.
• Serve as a protocol liaison with clinical t