Clinical Research Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

10h

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 collection and submission, and research documentation. The coordinator collaborates with Data Coordination staff on the Clinical Research Support team and works as part of specialized Oncology research teams. The position reports to the Senior Manager/Manager of Clinical Trials Coordination. The coordinator conducts study operations in accordance with protocols, regulatory and GCP guidelines, and institutional policies. The role develops and maintains study implementation tools, provides protocol-specific education and training, coordinates participant enrollment and visits, supports clinical and laboratory procedures, handles research specimens and supplies, and maintains accurate study records. The coordinator also serves as a protocol liaison, supports monitoring visits and query resolution, tracks billable activities, and maintains knowledge of research regulations and best practices. Travel between the South Lake Union campus and UW Medical Center Montlake is required to oversee transit of research specimens for processing and shipment; travel to industry-sponsored investigator meetings may also be required.

Requirements

High school diploma or equivalent.
Two to three years of experience in a clinical research or cancer registry environment with 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'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.
Previous experience working 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.
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 apply judgment in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns.

Responsibilities

Conduct daily clinical operations for assigned 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 tools as needed.
Provide study-specific education and training to clinic staff, participants, and other stakeholders.
Review medical records for study eligibility, initiate enrollment, ensure informed consent, and maintain accurate enrollment records.
Schedule clinic and study visits and ensure administrative compliance with protocols for clinical procedures, laboratory tests, and other participant activities.
Administer study questionnaires, perform non-clinical ECGs, and support investigational product accountability activities when applicable.
Complete clinical requisition forms, assemble visit kits, transport laboratory samples, ensure samples are processed and shipped according to study guidelines, and track research supplies.
Identify, track, and confirm patient billable activities; work with internal partners on budget and billing information and assist with charge review when applicable.
Serve as a protocol liaison with clinical teams, patients, providers, sponsors, and research staff.
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 professional development.
Maintain source documentation and enter case report form data, ensuring study records are timely, accurate, and complete.
Travel between the South Lake Union campus and UW Medical Center Montlake to oversee transit of collected research specimens for processing and shipment.
Travel to industry-sponsored investigator meetings when applicable.
Perform other duties as assigned.