Clinical Research Coordinator I/II

Fred Hutchinson Cancer Center•Seattle, WA

3d•Hybrid

About The Position

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. The Clinical Research Coordinator I or II (CRC) will be responsible for clinical trial coordination activities including participant enrollment, data collection and storage, participant communication, and interfacing with the larger study team. The CRC also supports all administrative and day-to-day trial operations. This individual will work under the supervision of the Principal Investigator, Project Manager, and Staff Scientist and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines. The CRC also supports outreach, engagement, and patient-facing activities within the PATCHES lab. The primary responsibility of this CRC will be to support an ongoing clinical trial of lung cancer screening in American Indian tribal health settings in Washington State. This role will have the opportunity to work in a hybrid setting. Evening and/or weekend work may occasionally be required. The CRC must have reliable personal transportation to travel between study sites and other assigned locations as needed to perform the essential functions of the position.

Requirements

High school diploma or equivalent.
Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections (for CRC I).
Minimum two to three years’ experience in a clinical research or cancer registry environment with regulatory or human research protections (for CRC II).
Demonstrated knowledge of how to synthesis study conduct.
Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
Knowledge of clinical trials records, procedures, and computerized data processing systems (for CRC II).
Reliable personal transportation to travel between study sites and other assigned locations as needed.

Nice To Haves

Bachelor’s degree or equivalent experience (for CRC I).
One to two years’ experience in a clinical research or cancer registry (for CRC I).
Prior exposure in REDCap, clinicaltrials.gov, electronic health records (EHR), and CTMS.
Interest in working in lung cancer screening and tobacco cessation.
Interest in working with tribal communities in Pacific Northwest and Alaska.
Ability to develop and/or present content to internal team and external groups.
Flexibility with work schedule as needed: in-person work will be driven by research patient visits, which will be variable. Managing patient visits may occur before or after regular work hours and some on the weekends.
Able to provide own transportation to travel to collaborating sites (local and regional) to perform research activities and outreach initiatives.
Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
Minimum five years of experience in a research environment with regulatory or human research protections (for CRC II).
Ability to extract data from medical records (for CRC II).

Responsibilities

Travel to South Puget Intertribal Planning Agency (SPIPA) sites approximately 2 times per week to provide coordination activities for the SACRED LUNGS clinical trial.
Recruit, screen, consent, and enroll eligible participants in accordance with study protocols and regulatory requirements.
Coordinate participant visits and study activities, including scheduling, follow-up, retention efforts, and participant compensation.
Maintain accurate and timely study documentation and data entry of participant enrollment, consent, study procedures, and payments in REDCap, Clinical Trial Management System (CTMS), and other clinical research databases.
Collaborate closely with SPIPA tribal partners, tribal clinics and community stakeholders to ensure culturally responsive and protocol-compliant study implementation.
Attend Community Advisory Board (CAB) meetings, document meeting outcomes, track attendance and compensation, and integrate community feedback into study operations.
Support collection, management, and preliminary analysis of qualitative and quantitative research data.
Assist with dissemination of study findings through presentations, reports, manuscripts, and community-facing materials.
Ensure compliance with institutional, federal, tribal, and sponsor regulations related to human subjects’ research and data confidentiality.
Prepare and maintain regulatory documentation, study records, and participant files in accordance with CITI Good Clinical Practice (GCP) guidelines.
Monitor study progress and assist with tracking recruitment, retention, and study milestones.
Participate in team meetings, protocol trainings, and quality assurance activities to support ongoing study operations.
Provide day-to-day coordination for other clinical research studies including monitoring study participants; obtaining consent; collecting, cleaning, and organizing study data; and communicating with study staff.
Work in collaboration with Fred Hutch Cancer Center clinical staff to coordinate patient data collection and study visits.
Work in collaboration with principal investigator and study staff to ensure that patients are enrolled on studies in an efficient manner.
Coordinate and manage patient study data, including upload and maintenance of patient data in REDCap system.
Develop and implement data tracking systems, ensuring hard copy and computer files are regularly and accurately maintained.
Coordinate protocol activities to ensure that protocol requirements are completed, which may include tracking subject enrollment, recording adverse events of study procedures and completing case report forms.
Maintain study records and complete case report forms.
Manage submissions and modifications to Institutional Review Board and other regulatory bodies.
Assure compliance with local and federal regulations.
Develop and prepare regular and special reports.
Work/communicate with study sponsor and assist with study monitoring visits.
Train, onboard, and provide guidance to junior research staff, students, and volunteers on study procedures and research compliance requirements.
Independently manage day-to-day operations of one or more clinical research studies, including participant recruitment, enrollment, retention, and study closeout activities.
Independently identify operational challenges and implement process improvements to support efficient study conduct.
Prepare, submit, and maintain Institutional Review Board (IRB) applications, amendments, continuing reviews, and study regulatory documentation with minimal supervision.
Other related duties as assigned.