Compliance Operations Coordinator

$76,606 - $114,878/Yr

Fred Hutchinson Cancer Center - Seattle, WA

Full-time - Mid Level

Seattle, WA

About the position

Fred Hutchinson Cancer Center is seeking a Compliance Operations Coordinator to oversee the Cancer Consortium's centralized clinical trial data and safety oversight committees supported by the Clinical Research Support (CRS) Compliance Team. This role is crucial in assessing and determining operational logistics for the data and safety committees, conducting data analysis of metrics for both non-industry and industry-sponsored oncology clinical trials, and evaluating the impacts of data to identify trends that lead to process and policy improvements in research and clinical settings. The incumbent will work under minimal supervision and will report to a supervisor for process direction. The Compliance Operations Coordinator will also support the training of committee and study team members in central CRS-supported committees and the CRS Auditing and Monitoring program's standard practices and workflow implementation. This position requires collaboration with internal and external regulatory and compliance specialists to manage and iterate on all CRS Compliance workflows. The incumbent will develop and refine best practices for a centralized committee model and will serve as a subject matter expert for research compliance processes, maintaining institutional knowledge of committee and compliance requirements. In this role, the Compliance Operations Coordinator will manage consortium committee and sponsor timelines, ensuring that all requirements are executed accurately and expeditiously. They will engage with consortium committee and study team members to ensure adherence to review timeliness and will project manage the standardization of consortium committee services. The position will lead efforts that facilitate centralized data analysis in support of institutional goals and will create comprehensive standard operating procedures (SOPs), work instructions, reviewer forms, and meeting templates for CRS Compliance programs and supported committees.

Responsibilities

• 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.
• Report Consortium committee outcomes to Investigators, study teams, internal and external stakeholders to ensure transparency throughout the committee review process in support of larger strategic initiatives.

Requirements

• Minimum 2 years' experience in clinical research, preferably oncology.
• Bachelor's Degree or equivalent years of experience.
• Demonstrated ability to deliver outcomes in fast paced environments.
• Demonstrated ability to work as an effective member of an interdisciplinary team.
• Demonstrated skills in critical thinking and problem solving.
• Ability to process complex documents and extract key information.
• Strong working knowledge of IT platform development.
• Familiarity with project management tools and techniques.
• Proficiency in use of Excel, MS Word, and Acrobat.
• Strong verbal and written communication skills.
• Strong attention to detail and ability to work according to CRS central office standards and best practices.

Nice-to-haves

• Clinical research-related certification.
• Project Management Professional (PMP) certification.
• Experience with Tableau or other data visualization tools.
• Previous experience with FDA, GCP, NIH, and OHRP regulations and medical terminology.

Benefits

• Paid parental leave
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• Tuition reimbursement
• Parental leave
• Employee assistance program
• Vision insurance
• Sabbatical
• Paid sick time