Clinical Research Coordinator III

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Senior Clinical Research Coordinator III works with hospital, clinic, and research staff to develop, implement, and manage clinical trials across a diverse research portfolio. The role coordinates the collection, processing, analysis, and quality control of clinical-trial data in accordance with protocol requirements and applicable regulations, including FDA oversight. It also coordinates long-term follow-up activities and supports research operations. Using independent judgment and advanced knowledge of clinical research processes, the 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 the Fred Hutch/Seattle Children's/UW system. Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the coordinator serves on the Clinical Trial Support Team and provides flexible support across disease programs and care settings. Assignments may address staffing coverage, enrollment growth, study startup, regulatory support, and other operational priorities. The role is expected to integrate quickly into new study teams and mentor less experienced staff.

Requirements

Bachelor’s degree in a scientific or medical field, or an equivalent combination of education and experience.
Six or more years of experience in medical records, cancer registry, clinical study coordination, or a related field.
Ability to work independently and prioritize work in a dynamic environment.
Collaborative approach and ability to work across multidisciplinary teams, including clinical teams.
Resourcefulness and problem-solving ability, with willingness to seek guidance when needed.
Comfort working in a clinic setting and interacting with patients.
Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs).
Exceptional interpersonal skills in person and on telephone calls.
Strong written and verbal communication skills.

Nice To Haves

Clinical research-related professional certification.
Experience with electronic medical records (EMR) and a clinical trial management system (CTMS).
Knowledge of FDA regulations, GCP guidelines, and other applicable regulations.

Responsibilities

Review assigned research protocols and study portfolios, including data collection, study conduct, and protocol requirements.
Research, maintain, analyze, and abstract patient clinical-trial data from pre-study history through trial participation and long-term follow-up.
Evaluate patient eligibility and assist with screening, enrollment, and onboarding across disease programs and research teams.
Coordinate 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 potential and active trial participants and support continuity of follow-up during staffing transitions and coverage assignments.
Manage long-term follow-up evaluations and data collection with 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.
Work with computer application specialists to ensure consistency between paper and electronic data systems.
Manage sponsor- or investigator-conducted monitoring visits and quality-control reviews, and support institutional monitoring visits to ensure data quality, completeness, and regulatory compliance.
Serve as a liaison and reference resource for physicians, investigators, study teams, sponsors, and other organizations on 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 on program policies, procedures, and goals.
Coordinate reports with the PI and Clinical Research leadership for the Human Subjects Committee, Institutional Review Board, Radiation Safety Committee, FDA, sponsors, and other regulatory agencies.
Liaise with IRBs regarding protocol submissions, amendments, annual reporting, continuing reviews, and adverse-event reporting.
Provide temporary operational support during staffing vacancies, leaves, enrollment surges, study startup, and other business needs.
Train, guide, and onboard less experienced staff as a senior resource and mentor.
Oversee data management for assigned research projects and support quality-assurance efforts.
Integrate rapidly into new disease programs, study portfolios, and research teams while maintaining high-quality study conduct and participant support.
Perform other responsibilities as required.