Clinical Research Coordinator I

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

 

The Clinical Research Coordinator is responsible for day-to-day coordination of intervention Phase I-III clinical trials of various complexities. The position will perform tasks relating to the start-up, management and close-out of studies including implementing new study processes with relevant service areas, screening patients for eligibility, tracking patient visits, assuring adherence to protocol schedules of events, and maintaining study records.  The Coordinator will work independently on multiple studies for at least two investigators, augment CRC staff, provide back-up to the general team and provide regular updates on the progress of the studies.  The CRC I reports directly to the Clinical Program Operations Director.

Responsibilities

• Prepares study start-up templates and documentation including eligibility checklists, study-specific clinic orders and study calendars
• Serves as main point of contact with sponsors and keeps investigators informed about enrollment opportunities
• Screens and registers patients; ensures eligibility requirements are met
• Assures consent forms are completed correctly and in entirety and that the consent process is appropriately documented
• Proposes orders for study related clinic procedures such as blood draws, exams, infusions and other procedures according to protocol requirements; coordinates with clinic, pharmacy staff and other clinical service areas to ensure proper documentation and timing of research-related procedures
• Attends clinic visits to update concomitant medications and adverse events and assure subject understanding of study requirements
• Responsible for the maintenance of study databases, including the abstraction and entry of data and CRF interpretation, potentially with data coordinator assistance
• Identifies procedural problems, communicates to the PI and research manager, and completes patient safety net reporting
• Manages Serious Adverse Event reporting to study sponsors and the IRB
• Screens third party safety reports per institutional procedures
• Assures adherence to research protocols and maintains protocol deviation documentation
• Requests insurance authorization and assures the process is complete prior to initiation of study procedures
• Collaborates with study monitors and responds to findings
• Creates and maintains patient tracking tools; communicates status to sponsors, investigators, management and relevant departments
• Acts as a resource to physicians, investigators, other staff members, and other organizations regarding protocol procedures, data collection requirements and other study related operations
• Maintains OnCore records timely
• Maintains study financial trackers
• Keeps knowledge and skills current by completing mandated training and attending meetings with the study team and the Consortium, such as the monthly coordinator meeting, relevant brown bags, faculty and administrative presentations, and other opportunities of interest

Qualifications

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent. 
• Minimum one year experience in a clinical research or cancer registry