Clinical Research Coordinator II - Community Sites

Job Details Location: US-WA-Seattle Type: Regular Full-Time Overview Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality. At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. As a Clinical Research Coordinator II , you will play a critical role in the successful conduct of clinical trials within the oncology research portfolio. This position is responsible for the day-to-day coordination of Phase I-III interventional clinical trials and observational Cancer Control studies conducted across community-based research sites. Responsibilities include managing subject-level study activities from participant screening and enrollment through study completion, coordinating protocol-required visits and procedures, collecting and reporting study data, supporting research specimen collection and shipment, and maintaining accurate research documentation and regulatory compliance. Working closely with investigators, providers, sponsors, and community site clinical teams, you will serve as a key resource for protocol implementation and participant engagement while ensuring studies are conducted in accordance with protocol, GCP, regulatory requirements, and institutional policies. This role is an integral part of our expanding community site clinical trials program, supporting access to innovative cancer clinical trials closer to where patients live and receive care. Reporting to the Manager of Community Site Clinical Research Operations, you will be a member of the Fred Hutch Overlake, Fred Hutch Evergreen, and Fred Hutch Northwest Oncology clinical research teams. At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect. Responsibilities Conduct daily clinical operations of assigned research studies in accordance with study protocols, GCP, regulatory requirements, and institutional policies. Support study startup and site activation activities, including collection of regulatory documentation, completion of study-specific training, implementation of study workflows, and preparation for site initiation activities. Develop, maintain, and utilize study implementation tools, including data collection forms, study reference materials, visit guides, and workflow documents. Provide study-specific education and training to clinic staff, participants, and other stakeholders to support accurate and compliant protocol implementation. Coordinate patient enrollment and participation by identifying potential study participants, reviewing medical records for eligibility, facilitating informed consent, and maintaining accurate enrollment records. Support participant recruitment and retention activities, including participant outreach, education, and engagement strategies designed to promote study participation and completion. Schedule and coordinate participant visits in accordance with protocol requirements and study timelines. Ensure completion of protocol-required procedures, laboratory testing, questionnaires, investigational product accountability activities, and other study-related assessments as permitted by training and scope of practice. Complete clinical requisition forms, assemble visit-specific kits, process and ship research specimens according to protocol requirements, and maintain study supply inventories. Ensure timely, accurate, and complete source documentation, data entry, query resolution, and maintenance of study records in accordance with protocol and regulatory requirements. Identify, track, and confirm billable study-related activities; collaborate with internal partners to support budget development, billing processes, and compliance reviews. Serve as the primary study contact and protocol liaison for participants, providers, sponsors, clinical staff, and research teams. Collaborate with community-based providers, clinic staff, pharmacy, laboratory, imaging, and ancillary departments to ensure successful protocol implementation and participant care. Prepare for and coordinate sponsor monitoring visits; respond to monitor requests, resolve data queries, and address follow-up items in a timely manner. Identify, communicate, and appropriately **escalate** protocol, operational, participant safety, or compliance issues to research and clinical leadership. Maintain current knowledge of clinical research regulations, GCP, protocol requirements, and research best practices through ongoing professional development activities. May travel between community site locations to support study operations, research coverage, specimen management, training activities, and departmental meetings. Perform other duties as assigned. Qualifications

MINIMUM QUALIFICATIONS:

High school diploma or equivalent. Minimum two to three years' 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.

PREFERRED QUALIFICATIONS:

Associate or bachelor's degree preferred. Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA). Five years of experience in a research environment with regulatory or human research protections. Previous experience working with NIH, FDA and OHRP regulations and medical terminology. Excellent organizational skills, attention to detail, ability to problem solve and 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 including generating reports and sourcing data from systems. Ability to extract data from medical records and apply judgement in interpreting regulations, determining impacts, and knowing when to ... The hourly pay range for this position is from $31.83 to $47.73 and pay offered will be based on experience and qualifications. Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position. Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks). Additional Information We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at View email address on click.appcast.io or by calling View phone number on click.appcast.io. #J-18808-Ljbffr Fred Hutchinson Cancer Center (Fred Hutch)