Program Operations Specialist Department of Medicine, Division of Hematology & Oncology

Job Description

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Clinical Research Operations Compliance Specialist to join their Hematology Clinical Research Program.

Reporting to the Finance Manager of the Hematology Research team, the Clinical Research Operations Compliance Specialist (Program Operations Specialist) manages administrative, financial, and technical operations to promote the patient care, research, and operational objectives of the Hematology Clinical Research Program within the UW Division of Hematology & Oncology. The Specialist will work with the faculty and staff clinical and research teams to effectively facilitate work flow, promote a collaborative work environment, and provide management support for program operations, research projects, business operations and administrative operations.

Further, this position is responsible for grant and contract administration, clinical finance and budget performance, research protocol, and oversight of the day-to-day administrative operations for the Hematology Program. Work of this position is evaluated in terms of adherence to program goals, budgetary limitations, and compliance with applicable laws, regulations, and policies.

The Clinical Research Operations Compliance Specialist works on-site at the Fred Hutch Cancer Center (FHCC), and project work visits may be required at local affiliate locations. The position may be eligible to be considered for a hybrid telework work schedule, working remotely up to three day per week, once fully trained and demonstrating telework readiness.

• Serve as an expert program resource to inter-institutional faculty and staff regarding federal and institutional (UW and FHCC) compliance requirements as they relate to clinical trials.
• Audit clinical trials using the OnCore system to ensure budgets are full cost recovery, identifying areas of strength and weakness and ensuring maximum revenue opportunities.
• Understand the total costs and effort associated with clinical research and rapidly develop and defend appropriate budgets to support the research program.
• Direct staff to thoroughly evaluate both the financial, and the research capability of protocol feasibility and advise Research Managers, Start-up Lead, and Finance manager to communicate the feasibility to the PI’s, including explicitly stating the effect of a deficit ending trial, in accordance with the UW GIMs.
• Provide guidance and counsel to faculty and staff to help facilitate the Division's ability to achieve scientific and educational goals.
• Monitor clinical trial contract terms and conditions, ensuring compliance with payment terms.
• Partner with Research Manager, faculty, and fiscal staff to strengthen clinical research revenue cycle operations, ensuring smooth and efficient functioning with a goal of standardization.
• Develop tools and metrics to track and analyze implemented process for improvements.
• Interpret, analyze, and implement all institutional, state, and federal policies relates to clinical research fiscal cycle administration including Medicare Clinical Trials Policy and Medicare Secondary Payer Rule; function as subject matter expert on such policies.
• Review study calendars, billing grids, and budget entry information within the Clinical Trial Management System (CTMS) to ensure efficient and compliant research revenue cycle operations.

• Analyze and understand clinical research budgets, financial needs, and contract language.
• Monitor contract terms and conditions, ensuring compliance with payment terms.
• Manage and review clinical billing charges, patient…