Clinical Research Coordinator 3 - Community Sites

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.

As a Clinical Research Coordinator III, you will play a critical role in the successful conduct of clinical trials within the oncology research portfolio. This position is responsible for the day-to-day coordination of complex Phase I-III interventional clinical trials and observational cancer research studies conducted across community-based research sites. Responsibilities include independently managing subject-level study activities from participant screening and enrollment through study completion, coordinating protocol-required visits and procedures, collecting and reporting study data, supporting research specimen collection and shipment, maintaining accurate research documentation and regulatory compliance, and serving as a resource for protocol implementation and study operations.

Working closely with investigators, providers, sponsors, Data Coordination staff, and community site clinical teams, you will help ensure studies are conducted in accordance with protocol requirements, Good Clinical Practice (GCP), regulatory requirements, and institutional policies. This role is an integral part of our expanding community site clinical trials program, supporting access to innovative cancer clinical trials closer to where patients live and receive care.

Reporting to the Clinical Research Manager, Community Sites, you will be a member of the Clinical Trials Coordination (CTC) team within Clinical Research Support (CRS), supporting the Fred Hutch Overlake, Fred Hutch Evergreen, and Fred Hutch Northwest 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

• Independently manage complex clinical trials and assume responsibility for significant study operations from activation through study closeout.
• Coordinate day-to-day conduct of oncology clinical trials across community-based research sites, including participant screening, eligibility review, informed consent activities, enrollment, study visit coordination, data collection, and protocol implementation.
• Serve as a primary operational resource for investigators, providers, clinical staff, ancillary departments, and research teams regarding protocol requirements, study procedures, and research-related processes.
• Collaborate with investigators, providers, and research leadership to develop and implement effective participant recruitment, enrollment, and retention strategies.
• Support study startup and site activation activities, including review of study requirements, workflow development, staff education, regulatory readiness, and implementation of study-specific procedures.
• Ensure timely, accurate, and complete research documentation, source documentation, data entry, query resolution, and maintenance of study records in accordance with protocol, regulatory, and institutional requirements.
• Interface with sponsors, monitors, CROs, and study partners; coordinate monitoring visits; resolve study queries; facilitate protocol implementation; and support audit and inspection readiness activities.
• Identify, investigate, and escalate protocol deviations, operational challenges, participant safety concerns, and compliance issues as appropriate; assist in developing and implementing corrective actions.
• Conduct quality review activities and periodic audits of study conduct, documentation, and data; identify opportunities for process improvement and support implementation of corrective and preventive actions.
• Provide guidance, training, mentorship, and day-to-day support to less experienced clinical research staff; contribute to onboarding and knowledge-sharing activities.
• Coordinate and oversee research specimen collection, processing, tracking, and shipment in accordance with protocol, sponsor, laboratory, and regulatory requirements.
• Collaborate with community clinic staff, pharmacy, laboratory, imaging, and ancillary departments to support successful protocol implementation and participant care.
• Maintain current knowledge of clinical research regulations, GCP, oncology research practices, and protocol requirements through ongoing professional development activities.
• May travel between community site locations to support study operations, staff coverage, training, monitoring visits, and departmental initiatives.
• Perform other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in scientific/medical field or equivalent combination of education and experience.
• Minimum six years’ experience working in clinical research, medical records, cancer registry, clinical study coordination or related field.

PREFERRED QUALIFICATIONS:

• Clinical research-related professional certification preferred.
• Experience working with electronic medical records (EMR) and a clinical trial management system (CTMS) is preferred.
• Knowledge of FDA regulations, GCP guidelines, and other applicable regulations.
• Ability to work independently and prioritize work in a dynamic environment.
• Collaborative and skilled working across multidisciplinary teams including clinical teams.
• Resourceful and able to solve problems, yet seek guidance when needed.
• Comfortable working in clinic setting and interacting with patients.
• Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs).
• Exceptional interpersonal skills both in-person and on telephone calls.
• Strong written and verbal communication skills.

The annual base salary range for this position is from $80,172 to $117,811, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).

Additional Information

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at [email protected] or by calling 206-667-4700.