Clinical Research Coordinator II - NCTN

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Clinical Research Coordinator II coordinates day-to-day National Clinical Trials Network (NCTN) clinical trials and associated research studies. The role oversees subject-level workflows, including eligibility screening, enrollment, visit tracking, study data abstraction and reporting, research specimen collection and submission, and maintenance of research documentation. The coordinator collaborates with investigators, clinical teams, and Data Coordination staff to support high-quality, compliant study conduct. Reporting to the Senior Manager/Manager of Clinical Trials Coordination, this position is part of a centralized NCTN research team supporting trials across multiple disease programs and care settings. As a shared departmental resource, the coordinator may support study activation, enrollment, participant follow-up, and ongoing trial operations across Fred Hutch campuses and affiliated clinical sites. The role regularly travels between campuses, affiliated clinical sites, and other research locations.

Requirements

High school diploma or equivalent.
Two to three years of experience in a clinical research or cancer registry environment involving regulatory or human research protections.
Knowledge of clinical trials records, procedures, and computerized data processing systems.
Demonstrated knowledge of how to synthesize study conduct.

Nice To Haves

Associate or bachelor's degree.
Certified Clinical Research Coordinator (CCRC) or Clinical Research Professional certification (SOCRA).
Five years of experience in a research environment involving regulatory or human research protections.
Previous experience with NIH, FDA, and OHRP regulations and medical terminology.
Excellent organizational skills, attention to detail, problem-solving ability, and ability to prioritize competing tasks in a dynamic environment.
Collaborative focus and strong written and verbal communication skills, including computer skills.
Ability to work with multiple data management systems, generate reports, and source data from systems.
Ability to extract data from medical records.
Ability to apply judgment when interpreting regulations, determining impacts, and deciding when to escalate questions and concerns.

Responsibilities

Conduct daily operations for assigned research studies in accordance with study protocols, regulatory and Good Clinical Practice (GCP) guidelines, institutional policy, and applicable NCTN requirements.
Develop, maintain, revise, and use study implementation tools, including data collection tools, reference materials, and study-specific orders.
Create and distribute educational content for internal and external audiences to support safe and accurate protocol implementation.
Review medical records to assess study candidate eligibility, coordinate enrollment and informed consent, and maintain accurate enrollment records.
Schedule clinic and study visits and ensure compliance with protocol requirements for clinical procedures, laboratory tests, and other patient activities.
Administer study questionnaires as applicable, ensure accountability for patient self-administration of study drugs, and perform non-clinical ECGs as applicable.
Support NCTN study activation, enrollment, conduct, and follow-up across disease programs and clinical practice areas.
Complete clinical requisition forms, assemble patient visit kits, transport laboratory samples, ensure sample processing and shipping follow study guidelines, and track research supplies.
Identify, track, and confirm billable patient activities; work with internal partners to obtain and submit budget and billing information; and assist with reviewing patient charges for billing compliance as applicable.
Serve as a protocol liaison with clinical teams, patients, providers, cooperative group representatives, and research staff.
Prepare and coordinate monitoring visits; respond to monitor and cooperative group queries and requests, and follow up to resolve issues.
Maintain field knowledge by attending meetings and symposia, reading relevant literature, maintaining professional associations, and participating in cooperative group activities as applicable.
Travel between Fred Hutch campuses, affiliated clinical sites, and other research locations to support enrollment, study visits, research operations, protocol activities, and investigator meetings.
Assist with maintaining source documentation and/or entering case report form data.
Provide flexible shared support across disease teams and clinical practice areas to facilitate NCTN study conduct, enrollment, and operational continuity.
Integrate into new disease programs, study portfolios, and clinical teams while maintaining high-quality study conduct and participant support.
Perform other duties as assigned.