Clinical Research Coordinator II

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Clinical Research Coordinator ensures all administrative and day-to-day operations of investigator-initiated and industry-sponsored human subjects clinical trials are completed in a timely and compliant manner.

Responsibilities

This individual will work under limited supervision of the Clinical Program Operations Director and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines. The current study portfolio focuses on supportive care, quality of life and outcome drivers for stem cell transplant recipients.

• Conduct daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
• Develop and maintain tools for study implementation, including data collection tools, reference materials and specific study orders; revise and utilize tools as necessary.
• Create and disseminate study-related educational content for internal and external audiences to ensure safe and accurate protocol implementation.
• Coordinate patient enrollment and participation by reviewing study candidates’ medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
• Schedule patient clinic visits and on-going study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities; may administer study questionnaires, ensure drug self-administration accountability with patients and perform non-clinical ECGs.
• Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
• Identify, track and confirm billable activities for patients; work with internal partners to obtain and submit budget and billing information; may assist in reviewing patient charges to ensure billing compliance.
• Act as protocol liaison with clinical teams, patients, and providers on study related topics.
• Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up with and resolving any issues that may arise.
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature and maintaining professional associations.
• May travel to attend industry-sponsored investigator meetings.
• Assist with maintaining appropriate source documentation and/or performing case report form data entry.
• 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.
• Excellent organizational skills,