Clinical Research Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

17d

About The Position

The Clinical Research Coordinator II coordinates interventional Phase I–III clinical trials and observational Cancer Control studies, providing flexible support across disease programs, research teams, and community sites. The role manages subject-level study activities, including participant screening and enrollment, visit coordination, study documentation, data collection and reporting, and research specimen management. The coordinator collaborates with investigators, study teams, and Data Coordination staff within Clinical Research Support to ensure successful study execution and continuity of research operations. Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the coordinator serves on the Clinical Trial Support Team. Assignments may shift to address staffing coverage, enrollment growth, study startup, and other operational priorities. The position requires rapidly integrating into new study teams while maintaining high-quality study conduct in accordance with protocols, regulatory requirements, and institutional policies. Fred Hutchinson Cancer Center is an independent nonprofit organization focused on adult cancer treatment and research in cancer and infectious diseases. It operates clinical care sites and hospital network affiliations. Employees are expected to demonstrate the organization’s values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

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 trial records, procedures, and computerized data processing systems.
Demonstrated knowledge of how to synthesize study conduct.
Strong organizational skills, attention to detail, problem-solving ability, and ability to prioritize competing tasks in a dynamic environment.
Strong written and verbal communication skills and 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 escalating questions and concerns when appropriate.

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 with NIH, FDA, and OHRP regulations and medical terminology.

Responsibilities

Conduct daily clinical operations of assigned research studies in accordance with protocols, regulatory and GCP guidelines, institutional policies, and organizational priorities.
Develop and maintain study implementation tools, including data collection tools, reference materials, and study orders; revise and use them to support continuity and efficient onboarding.
Provide study-specific education and training to clinic staff, participants, and other stakeholders.
Review medical records for study eligibility, coordinate participant enrollment, initiate enrollment, ensure informed consent, and maintain enrollment records.
Schedule clinic and study visits and ensure protocol-required clinical procedures, laboratory tests, and other participant activities are coordinated; may administer questionnaires, perform non-clinical ECGs, and support investigational product accountability activities.
Provide temporary operational support for staffing vacancies, leaves, enrollment surges, study startup, and other business needs.
Complete clinical requisition forms, assemble visit kits, transport and process laboratory samples, arrange shipping according to study guidelines, and track research supplies.
Identify, track, and confirm billable patient activities; work with internal partners on budget and billing information and may review patient charges for billing compliance.
Serve as a protocol liaison with clinical teams, patients, providers, sponsors, and research staff across studies and disease programs.
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 practices through professional development and cross-training.
Maintain source documentation and enter case report form data, ensuring study records are timely, accurate, and complete.
May travel between clinical and research locations, including Community Sites, to support study operations, participant visits, specimen handling, monitoring, and other research responsibilities.
Integrate rapidly into new research teams, disease programs, and study portfolios while maintaining quality study conduct and participant support.
Perform other duties as assigned.