Clinical Research Coordinator Lead

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

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. This role leads and supports the implementation and coordination of clinical trials, with a focus on trial startup, operational readiness, and cross-functional collaboration. It plays a key role in driving efficient trial activation, ensuring high-quality execution, and maintaining compliance with regulatory and institutional standards. Responsibilities include supporting the trial startup lifecycle, mentoring research staff, drive solutions for multifaceted challenges and contributing to the development of SOPs and operational tools. The role also supports patient coordination for complex and early-phase trials and ensures audit and monitoring readiness across the research portfolio. Reporting to the Senior Manager/Manager of Clinical Trials Coordination you will be part of the Breast Oncology, Genitourinary Medical Oncology, or other specialized Oncology clinical research teams.

Requirements

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 to others in the ongoing development of clinical research skills

Nice To Haves

Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SoCRA), or equivalent certification
Previous experience in oncology research

Responsibilities

Coordinate patient care and logistics for complex and early-phase clinical trials, including subject enrollment, visit planning, data collection, and coordination with clinical teams.
Support research protocol monitoring and auditing visits, ensuring timely resolution of queries and implementation of corrective and preventive actions.
Lead and mentor Clinical Research Coordinators (CRCs I–III) through onboarding, workflow coaching, Central Trial Brain guidance, and ongoing professional development, while providing technical direction and performance oversight.
Develop and maintain team SOPs, tools, and operational resources, collaborating with CRS Compliance and cross‑functional stakeholders to ensure alignment with consortium policies and evolving operational needs.
Perform quality assurance and quality control activities to ensure adherence to study protocols, regulatory requirements, and institutional standards.
Develop and maintain team Standard Operating Procedures (SOPs) and operational tools in collaboration with CRS Compliance to ensure alignment with consortium policies.
Support the full clinical trial startup lifecycle—from CDA routing through SIV and CRS SSU handoff—by coordinating Pre-Study Visits (PSVs), Site Qualification Visits (SQVs), feasibility assessments, and sponsor communications, while collaborating with Research Managers and cross-functional teams to ensure timely and efficient trial activation.
Contribute to the development and review of Order Builds, Research Treatment Plans, and Fact Sheets to align with clinical workflows and patient coordination, while participating in meetings such as Orders Validation, Clinical Readiness, and faculty disease group reviews to support protocol alignment and early trial assessments.
Other duties as assigned.