Lead Clinical Research Coordinator

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 Lead Clinical Research Coordinator leads clinical trial coordination activities for an Oncology clinical research portfolio that includes industry-sponsored, investigator-initiated, and national cooperative group clinical trials. The role is also responsible for team development activities such as training, quality assurance, and maintaining SOPs and tools. The Lead Clinical Research Coordinator is a position within the central clinical trials office, Clinical Research Support (CRS), and part of our central clinical trial coordination team. The team provides research operational support to Principal Investigators (PIs) and research study teams focused on growing our mission-critical clinical trials programs. The incumbent will report to the Senior Manager, Clinical Trials Coordination. 

 

Reporting to the Senior Manager/Manager of Clinical Trials Coordination this incumbent will be part of specialized GI oncology clinical research teams.

 

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

PRIMARY/ESSENTIAL DUTIES:

• Serves as subject matter expert and provides technical direction to clinical research coordinator team.
• Performs day-to-day coordination of clinical trials including screening patients for protocol eligibility, ensuring informed consent has been properly obtained, enrolling subjects, planning/scheduling/tracking subject visits, collecting data, and coordinating with clinic staff.
• Performs quality assurance and quality control activities of the work performed by those within the CRC team ensuring study is conducted in accordance with the protocol, regulations, and Consortium policies.
• Leads training and mentoring of clinical research coordinator staff.
• Develops and maintains team’s SOPs and tools; collaborates with CRS Compliance to ensure alignment with Consortium policies.
• Works in close collaboration with the startup, finance, data, and regulatory teams and manages the coordination of activities ensuring timelines and expectations of the program are met.
• Collaborates with clinic providers and staff, ancillary services, and research staff regarding protocol implementation and operations.
• Serves as sponsor’s primary point of contact for active industry trials.
• Coordinates research protocol monitoring and auditing visits and takes action to ensure all outstanding queries and corrective actions are resolved.
• Leads and/or participates in the start-up of a study including things such as budget development, contracting, and protocol implementation.
• Performs additional duties as assigned.

SCOPE OF RESPONSIBILITY:

• Level of autonomy: High
• Financial responsibility: Coordinates patient reimbursements, understands clinical trial budgets and billing plans for patients enrolled on clinical trials

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor's degree
• Minimum of 6 years of experience in a clinical research setting
• Knowledge of regulations and guidelines for conducting clinical research; for example, Good Clinical Practice (ICH-GCP), Human Subjects Protection, etc.
• Experience with electronic medical records systems
• Strong written and verbal communication skills