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 Senior Clinical Research Coordinator III works directly with hospital, clinic, and research staff in the development, implementation, and management of clinical trials across a diverse research portfolio. The position is responsible for the collection, coordination, processing, and quality control of clinical trial data in accordance with protocol requirements and applicable regulatory guidelines, including studies subject to FDA oversight. The Senior Clinical Research Coordinator also coordinates long-term follow-up activities associated with assigned studies and supports the successful execution of research operations.

Using independent judgment and advanced knowledge of clinical research processes, the Senior Clinical Research Coordinator leads data collection, quality control, regulatory, and research coordination activities. The position interacts with patients, physicians, sponsors, investigators, and clinical and research staff within and outside of the Fred Hutch/Seattle Children's/UW system.

Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the coordinator will serve as part of the Clinical Trial Support Team, providing flexible clinical research coordination support across disease programs and care settings. This role may be deployed to support staffing coverage needs, enrollment growth, study startup activities, regulatory support, and other operational priorities while ensuring continuity of research operations. The Senior Clinical Research Coordinator is expected to rapidly integrate into new study teams and serve as a resource and mentor to less experienced staff.

This position is key to the successful conduct of clinical trials and advancing research efforts at Fred Hutch.

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

- Review and maintain familiarity with assigned research protocols and study portfolios with regard to data collection, study conduct, and protocol requirements.

- Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up.

- Evaluate patient eligibility for clinical trials and assist in screening, enrollment, and onboarding activities across multiple disease programs and research teams.

- Understand and interact with departments and automated systems throughout the Fred Hutch/Seattle Children's/UW system to ensure timely and complete delivery of data and study-related information.

- Track status of potential and active clinical trial participants and support continuity of participant follow-up during staffing transitions and coverage assignments.

- Manage long-term follow-up evaluations and data collection with clinical trial participants, Fred Hutch/Seattle Children's, and participants' local physicians.

- Develop data acquisition forms, study tools, and instructions to support consistent study implementation and operational efficiency across assigned studies.

- Manage and work with computer application specialists to ensure consistency between paper and electronic data systems.

- Manage monitoring visits and quality control reviews conducted by Sponsors or Investigators.

- Support regularly scheduled institutional monitoring visits by Sponsors or Investigators to ensure quality, completeness, and regulatory compliance of study data.

- Serve as a liaison and reference resource to Physicians, Investigators, study teams, sponsors, and other organizations with questions regarding protocol procedures, data collection, and study requirements.

- Manage special projects related to study startup, data collection, analysis, reporting, process improvement, and operational priorities.

- Provide input to support program policies, procedures, and goals. Coordinate submission of reports in conjunction with the PI and Clinical Research leadership to the Human Subjects Committee, Institutional Review Board, Radiation Safety Committee, Food and Drug Administration, Sponsors, and other regulatory agencies.

- Liaise with Institutional Review Boards (IRBs) regarding protocol submissions, study amendments, annual reporting, continuing reviews, and adverse event reporting.

- Provide temporary operational support during staffing vacancies, leaves of absence, enrollment surges, study startup activities, and other identified business needs to ensure continuity of research operations.

- Serve as a senior resource and mentor to less experienced staff by providing training, guidance, and onboarding support.

- Oversee data management activities for assigned research projects and support quality assurance efforts.

- Demonstrate the ability to rapidly integrate into new disease programs, study portfolios, and research teams while maintaining high-quality study conduct and participant support.

- Perform other responsibilities as required.

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.

- 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.