Clinical Research Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Clinical Research Coordinator II coordinates day-to-day operations for interventional Phase I–III clinical trials and observational Cancer Control studies. The role oversees subject-level workflows, including screening patients for eligibility, enrollment, visit tracking, study data abstraction and reporting, research specimen coordination, and research documentation. The coordinator collaborates with Data Coordination staff on the Clinical Research Support team and is part of specialized oncology research teams. The position reports to the Senior Manager/Manager of Clinical Trials Coordination. The coordinator supports the compliant implementation and smooth operation of clinical studies by working with patients, clinic staff, providers, sponsors, monitors, and research teams. Duties include scheduling and coordinating study activities, maintaining accurate records, processing and shipping specimens, supporting billing compliance, and keeping current with clinical research regulations and best practices. Travel between the South Lake Union campus and UW Medical Center Montlake is required to oversee research specimen transit. Industry-sponsored investigator meeting travel may also be required.

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 trial records, procedures, and computerized data processing systems.
Demonstrated knowledge of how to synthesize study conduct.

Nice To Haves

Associate's or bachelor's degree in healthcare, life sciences, public health, or a related field.
Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP/SOCRA), or equivalent certification.
Experience coordinating clinical research studies, including participant enrollment, informed consent, study visits, data collection, and research documentation.
Experience with NIH, FDA, OHRP, and ICH-GCP regulations, clinical research databases, and electronic medical records.
Excellent organizational skills, attention to detail, problem-solving ability, and ability to prioritize multiple competing tasks in a dynamic environment.
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 and use judgment to interpret regulations, determine impacts, and know when to escalate questions and concerns.

Responsibilities

Conduct daily clinical operations for assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
Develop and maintain study implementation tools, including data collection tools, reference materials, and study-specific orders; revise and use them as needed.
Provide study-specific information to clinic staff, participants, and other stakeholders to support accurate, compliant protocol implementation.
Review medical records to determine study eligibility, initiate enrollment, ensure informed consent, and maintain enrollment records.
Schedule clinic and study visits and ensure administrative compliance with protocol requirements for clinical procedures, laboratory tests, and other patient activities.
As applicable, administer study questionnaires, perform non-clinical ECGs, and support investigational product accountability, participant education, documentation, reconciliation, and pill counts for participant-managed medications.
Complete clinical requisition forms, assemble patient visit kits, transport laboratory samples, ensure samples are processed and shipped according to 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, as applicable, help review patient charges for billing compliance.
Serve as a protocol liaison with clinical teams, patients, providers, sponsors, and research staff regarding study activities and requirements.
Prepare and coordinate monitoring visits, respond to monitor queries and requests, and follow up to resolve issues.
Maintain current knowledge of clinical research regulations, GCP, protocol requirements, and research best practices through ongoing professional development.
Maintain appropriate source documentation and enter case report form data, ensuring study records are timely, accurate, and complete.
Travel from the South Lake Union campus to UW Medical Center Montlake to oversee transit of collected research specimens for processing and shipment.
May travel to industry-sponsored investigator meetings.
Perform other duties as assigned.