Clinical Research Coordinator III

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 III will work directly with hospital, clinic and research staff in the development, implementation and management of clinical trials.

Responsible for the collection, coordination, processing, and quality control of clinical trial data in accordance with protocols subject to FDA oversight. They are responsible for coordination of long-term follow-up activities associated with these protocols.

Te incumbent will use judgment in data collection, quality control, liaison, and research coordination activities.  They will interact with patients, physicians, and other clinical providers and support staff within and outside of the Fred Hutch/Seattle Childrens UW system including the Fred Hutch Transplant Service. 

This role will have the opportunity to work partially at our campus and remotely.

Responsibilities

This individual will work under limited supervision of the Clinical Research Operations Manager and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines.

• Review and maintain familiarity with research protocols with regard to data collection.
• Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up.
• Evaluate patient eligibility for clinical trials and assist in screening and patient enrollment.
• Understand and interact with departments and automated systems throughout Fred Hutch/Seattle Childrens/UW system to ensure timely and complete delivery of data.
• Track status of potential and active clinical trial participants.
• Manage long-term follow-up evaluations and data collection with clinical trial participants, Fred Hutch/Seattle Childrens, and participants’ local physicians.
• Develop data acquisition forms and instructions for completion.
• Manage and work with computer application specialists to ensure consistency between paper and electronic data systems.
• Manage monitoring visits and quality control reviews by Sponsors or Investigators.
• Support regularly scheduled institutional monitoring visits by Sponsors or Investigators to ensure quality and completeness of data.
• Serve as a liaison and reference resource to Physicians, Investigators, other staff members, and other organizations with questions about data collection or protocol procedures and requirements.
• Manage special projects regarding data collection, analysis, output, and presentation.
• Provide input to support policies and goals of the program. Manage submission of reports in conjunction with the PI and Sr. Clinical Research Manager to the Human Subjects Committee, Institutional Review Board, Radiation Safety Committee, Federal Drug Administration, Pharmaceutical Companies, and other agencies.
• Liaise with Institutional Review Boards (IRB’s) in submission of protocol, study amendments, annual reporting and adverse event reporting.
• Assist with orientation and training of new staff.
• Perform other responsibilities as required.
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