Compliance Operations Coordinator

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.

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 committee review process for continuity with CRS standards and best practices.
• Manage communications and trackers to maximize transparency and efficiency from intake to completion.
• 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.
• Support CRS initiatives that will enable study teams to maximize overall protocol compliance and data reporting.

MINIMUM QUALIFICATIONS:

• 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.
• Working with multi-disciplinary teams.
• Forecasting and meeting deadlines.
• Communicating with all levels of a research organization.
• Strong working knowledge of IT platform development.
• Familiarity with project management tools and techniques.
• Familiarity with CTMS and systems to support workflow & metrics.
• 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.
• Excellent interpersonal skills and ability to build positive and professional working relationships with internal and external stakeholders. 
• Effectively able to communicate and demonstrate accountability in a remote setting.
• Ability to collaborate with stakeholders to create meaningful training resources to increase clinical research compliance.

PREFERRED QUALIFICATIONS:

• 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.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

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The annual base salary range for this position is from $76,606 to $114,878, and pay offered will be based on experience and qualifications.  

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months). 

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. 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 are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and 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 hrops@fredhutch.org or by calling 206-667-4700.