Clinical Research Coordinator Team Lead

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 Team Lead will assist in the coordination of complex oncology clinical studies and monitor the daily operations of team members. The role is also responsible for team development activities such as training, quality assurance, and maintaining SOPs and tools.  Based within the central clinical trials office, known as Clinical Research Support (CRS), this role is integral part of our rapidly expanding clinical trial coordination team focused on the advancement of mission-critical clinical trial programs.  Reporting to the Senior Manager/Manager of Clinical Trials Coordination the incumbent will be part of the Breast Oncology, Genitourinary Medical Oncology, or other specialized 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 complex 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
• 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.
• 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.
• Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree
• Minimum 6 years of experience in clinical research coordination
• 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
• Ability to understand and follow multiple complex protocols at multiple sites
• Ability to organize and manage time and tasks independently
• Ability to develop and/or present content to senior leaders and other groups
• Problem solving skills- education and training resource