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.

About this Opportunity

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. Furthermore, 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.

Key Responsibilities

Program Development, Research Administration, and Strategic Planning - 35%

• 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.

Budget and Contract - 20%

• 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 reimbursements, and stipends to ensure accuracy and compliance.
• Mid-trial audit, provide audit report to start-up and post-award team for budget amendment.

Protocol Development / Implementation - 20%

• Assist with the development and implementation of protocols, protocol-related documents, and protocol amendments for investigator-initiated trials

Staff Effort Management Planning - 20%

• Implement Ontario Protocol Assessment Level (Clinical Trial Complexity Rating Tool for Workload Planning in Oncology Clinical Trials)
• Coordinates and reviews the work of staff as related to the needs of their research program. Compare estimated personnel effort and actual effort spent and submit the report to research manager monthly
• Indirectly and directly supervise finance staff involved in post award grant and clinical trial management; serve as a consultant to faculty in personnel issues.
• Develop, implement, and oversee internal controls for payroll management for the program.

Other Related Tasks - 5%

• Other program development, research administration, and strategic planning tasks as assigned.

Required Qualifications

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Minimum Qualifications

• Bachelor's degree in science or health-related field and two years of experience in clinical research project coordination/management or related research or healthcare experience.

Applicants who do not meet these minimum qualifications WILL NOT be forwarded to the Hiring Manager

Additional Qualifications

• Knowledge of administrative requirements of clinical research projects and demonstrated ability to work in fast-paced clinical research program.
• Experience working in clinic research operations, including clinical trial financials, terminology, research practices, coordination, implementation, and analysis.
• Excellent written and verbal communication skills (i.e., demonstrated ability to communicate and work effectively both verbally and in writing with colleagues and study sponsor representatives).
• Strong organization skills and attention to detail, and demonstrated ability to prioritize multiple projects, simultaneously.
• Strong computer skills and competency with Microsoft Office software, including Microsoft Excel.

Preferred Qualifications

• Demonstrated ability to convey complex policy, financial, and scientific/technical information in a manner that is understandable to a wide audience.
• Prior working experience at the UWMC and/or FHCC or similar research, fiscal, and/or healthcare administration in a university or non-profit setting.
• Experience with clinical oncology patients.
• Knowledge of OnCore CTMS, EPIC, REDCAP
• Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, and interpreting complex implications of research protocols.
• Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations.

Working Conditions

• This position will work with limited supervision on multiple research projects; at times, without the benefit of written policies or procedures, while concurrently helping to create best practices moving forward. Up to 30 projects will be in progress simultaneously, with the expectation of additional projects in the future.
• This position requires a flexible work schedule and the ability to adjust to rapidly changing priorities and new projects. Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.
• This position will work with clinical research involving human subjects within UW Medicine; Clinical Research Coordinator (CRC) training is required. The training requirement for this position includes UW Medicine-specific, Fred Hutch-specific, and general training and will be required to complete it within 30 days of hire.

Compensation, Benefits and Position Details

Pay Range Minimum:
$89,400.00 annual
Pay Range Maximum:
$92,064.00 annual
Other Compensation:

Benefits:
For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a regular position
FTE (Full-Time Equivalent):
100.00%
Union/Bargaining Unit:
Not Applicable