Clinical Research Coordinator III

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 III works directly with patients, investigators, sponsors, physicians, and research staff in the implementation and management of complex clinical trials and research studies. Responsible for coordinating study activities, data collection and quality oversight, long-term follow-up, and research documentation in accordance with protocol, regulatory, and institutional requirements.

Uses independent judgment in research coordination, protocol implementation, data management, and problem resolution activities. Serves as a resource to research teams and supports study startup, monitoring, and audit readiness activities.

Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the coordinator will be part of specialized oncology clinical research teams supporting disease-specific programs such as Breast, Gastrointestinal (GI), Genitourinary (GU), Gynecologic (GYN), Sarcoma, and other oncology research areas.

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

- Maintain comprehensive knowledge of assigned research protocols, with particular emphasis on eligibility criteria, data collection requirements, treatment procedures, and long-term follow-up expectations.

- Independently manage complex clinical trial operations, including patient screening, eligibility assessment, enrollment, study conduct, and long-term follow-up activities in accordance with protocol and regulatory requirements.

- Independently collect, abstract, analyze, interpret, and oversee clinical trial data activities, ensuring data quality, integrity, completeness, and regulatory compliance.

- Lead cross-functional coordination across clinical, ancillary, administrative, regulatory, and research teams to support effective study execution and resolution of operational issues.

- Track and manage the status of potential, enrolled, active, and completed clinical trial participants and ensure protocol-required activities are completed accurately and within required timelines.

- Design, implement, and optimize study-specific source documents, data collection tools, workflows, and guidance materials to support protocol compliance and operational efficiency.

- Serve as the primary operational contact for sponsors, monitors, auditors, and internal quality reviewers; coordinate monitoring visits, support audit readiness, and address findings as needed.

- Coordinate and oversee protocol-required participant management and investigational product accountability activities, including participant education, reconciliation, documentation, drug diaries, and pill counts for participant-managed study medications, as applicable.

- Identify, investigate, and resolve complex protocol, operational, data quality, and compliance issues; implement corrective actions and escalate significant concerns as appropriate.

- Serve as a subject matter expert and trusted resource to investigators, clinicians, research staff, sponsors, and external stakeholders regarding protocol interpretation, study operations, and research best practices.

- Participate in study startup activities, including protocol review, workflow development, feasibility assessment, implementation planning, and operational readiness for complex clinical trials.

- Lead or contribute to special projects, process improvement initiatives, SOP development, workflow optimization, and implementation of best practices to enhance research quality, efficiency, and compliance.

- Provide training, mentorship, and functional guidance to CRC I/II staff and other research personnel; support onboarding and development of research competencies.

- Perform other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

- Bachelor’s Degree in scientific/medical field or equivalent combination of education and experience.

- Six or more years of experience in 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.

- Experience preparing for and participating in sponsor monitoring visits, audits, and regulatory inspections.

- Demonstrated experience training, mentoring, or serving as a resource for research staff.

- 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.