Clinical Research Coordinator I/II

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 I/II (CRC) will coordinate day-to-day activities for assigned clinical research protocols for the Infectious Disease Sciences Program while demonstrating competence in clinical research skills, problem-solving, and priority setting. This position supports COVID-19 and non-COVID-19 clinical research studies/trials.

Responsibilities

The incumbent will participate in the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects. This individual will work under the supervision of the Senior Clinical Research Manager and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Collaborate with a multi-disciplinary team and provide guidance to other study staff in carrying out research implementation tasks.

 

Perform some or all the following responsibilities assigned based on the level CRC I and or CRC II:

• Study Conduct / Clinical Research Practice
• Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols.
• Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
• Serve as project liaison, representing the project to other center departments, affiliated individuals or institutions, and outside organizations.
• On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
• Initiation and completion of Central Startup for both industry sponsored and PI initiated studies
• Collaborate with investigators and coworkers to ensure completion of study activities
• Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
• Screen and recruit subjects either within the consortium or the community dependent upon study specific requirements, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects.
• Travel to University of Medical Center and the Fred Hutch Outpatient Clinic will be required for the enrollment of study subjects.
• Ensure accurate enrollment records are maintained and up to date.
• Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
• Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
• Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.

 

 Protocol Development and Implementation

• Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans. 
• Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise