Compliance Operations Coordinator

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 Compliance Operations Coordinator will oversee the Cancer Consortium’s centralized clinical trial data and safety oversight committees supported by the Clinical Research Support (CRS) Compliance Team. The incumbent will be responsible for assessing and determining operational logistics for the data and safety committees, conducting data analysis of metrics for non-industry and industry-sponsored oncology clinical trials resulting from both internal and external auditing and monitoring functions, evaluating impacts of data, and identifying trends leading to process and/or policy improvements in research and clinical settings, and determining necessary workflows. The incumbent works under minimal supervision in operational matters and reports to supervisor for process direction.

 

This position will support training of committee and study team members to central CRS-supported committees and CRS Auditing and Monitoring program standard practices and workflow implementation in support of larger CRS strategic goals initiatives. This position will work with internal and external regulatory and compliance specialists to oversee, manage, and iterate on all CRS Compliance workflows.

 

This position will develop and continue to refine best practices for a centralized committee model. This position will be a subject matter expert for research compliance processes, non-industry and industry-sponsored oncology clinical trials, and maintain institutional knowledge of committee and compliance requirements and dependencies.

Responsibilities

PRIMARY/ESSENTIAL DUTIES:

• Manage consortium committee and sponsor timelines, ensuring that all requirements are executed accurately and expeditiously.
• Engage consortium committee and study team members to ensure adherence to review timeliness.
• Project manage and oversee standardization of consortium committee services to support fully centralized services from intake to completion.
• Lead efforts that facilitate centralized data analysis in support of institutional goals, best practices, NCI grant submissions, and standards contributing to larger CRS strategic initiatives that aim to increase quality, compliance and reduce subject safety events.
• Lead and optimize processes; determine and improve operational process standards based on feedback and data from internal and external partners.
• Ensure all compliance-related impacts are vetted and integrated by working proactively with central offices, clinic partners, faculty members and research collaborators.
• Create comprehensive standard operating procedures (SOPs), work instructions, reviewer forms, and meeting templates for CRS Compliance programs and supported committees.
• Other duties as assigned.

SCOPE OF RESPONSIBILITY:

• Serve as a subject matter expert in clinical trial data and safety committee operationalization, data analysis, and clinical research trends identification.
• Collaborate with pharmaceutical sponsors, institutional sponsors, and study teams to integrate and implement protocol amendment requirements.
• Manage source documentation and records practices throughout the Consortium co