Req #: 231208

Department: SCHOOL OF MEDICINE: CLINICAL TRIALS OFFICE

Job Location Detail: Office is in Seattle, Washington. However, this position has the flexibility to work fully remote in the US and we invite out of state applicants to apply.

Posting Date: 02/16/2024

Closing Info: Open Until Filled

Salary: $5,114 - $7,672 per month

Shift: First Shift

Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230119_a11y.pdf)

As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world.

UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.

The Clinical Trials Office has an outstanding opportunity for a Billing Compliance & QC Specialist to join their team.

UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists and other health professionals. Within the large UW Medicine health system, the School of Medicine (SOM) is a world leader in biomedical research, with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally.

The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SOM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.

The Billing Compliance & QC Specialist (payroll title: Program Operations Specialist) will perform comprehensive and independent final compliance review (Summary Review) of all documents related to research study funding, including the research study budget, protocol, contractual terms, informed consent, and other supporting documentation. The incumbent will additionally function as a subject matter expert with CTO production workflows and systems processes, and will offer suggestions for optimization strategies. This position will assist with training internal staff on processes and systems and will educate CTO customers on workflows and expectations. Ability to work collaboratively in a group setting in a fast-paced environment is crucial in this role.

The Clinical Trials Office is a central clinical research operation with compliance responsibilities and services across the vast portfolio of clinical trials in UW Medicine. The CTO operation has direct impact on UW’s reputation with major global biotech and biopharma sponsors, the availability of funded clinical trial opportunities in the UW pipeline, and UW patients' access to novel therapies. In addition, the CTO plays a key role in mitigating institutional financial and reputational risks by ensuring strict compliance with CMS and FDA regulations and guidelines. The Billing Compliance & QC Specialist is a key position in maintaining a secure and fully compliant CTO operation.

DUTIES AND RESPONSIBILITIES Workflow and Billing Compliance: • Perform comprehensive and independent analysis of systems processes pertaining to CTO review workflows. • Determine appropriate workflow pathway for proper routing of studies through the start-up process. • Perform Pre-CTO Admin Tasks import process for study submissions. • Perform Pre-Activation Checks for studies prior to transition to the CTO Billing Team for RSH Activation in Epic. • Perform CTO Inbox Management functions in the Zendesk (ZD) Customer Service Management tool. • Review and perform tasks from various Clinical Trial Management System (CTMS) OnCore reports, related to multiple workflows. • Understand and exercise independent judgment and discretion in the interpretation and application of the Medicare Clinical Trial Policy, and all relevant UW Medicine clinical research budgeting and billing policies and procedures. • Perform comprehensive and independent final compliance review (Summary Review) of all documents related to research study funding, including the research study budget, protocol, contractual terms, informed consent, and other supporting documentation. • Review and finalize study Billing Grids, ensuring proper documentation of Coverage Analysis decisions. • Regularly update and work with OnCore, ZD, the CTO Database (CTODB), Epic, and other comprehensive electronic study documentation for each clinical research study, in compliance with UW policies, procedures and standards. • Analyze, interpret, and apply internal and external research billing policies, assisting faculty, study staff, and clinical managers in determining applicable review requirements and facilitating timely budget approval. • Provide excellent customer service and accurate guidance to clinical research study teams and keep them apprised of study status. • Track studies through multiple milestone points in the CTO production database to inform analytics. • Manage production tickets and communications regarding work performed in compliance with office policies, procedures, and standards. • Ensure electronic and paper study files are created, updated, stored, and maintained according to established office practices, customer service standards, and UW record retention policies, from initial study submission to study closeout and beyond. • Effectively collaborate with and communicate important information to external investigators and research teams at partner institutions (e.g., Fred Hutchinson Cancer Center and Seattle Children’s). • Contribute to the development of the CTO website content, training materials, and SOPs. • Participate in internal and interdepartmental project teams within UW Medicine as assigned. • Under the guidance of the Manager and Sr. Workflow Lead, provide training for new and existing team members. • Perform other clinical research finance-related duties, as required.

Quality Check (QC): • Assist with implementing strategies to achieve and maintain the service and quality goals for the CTO Clinical Research Finance Team. • Offer suggestions for optimization strategies that contribute to CTO metrics and other analytics for internal and external audiences. • Assist with QC of workflows being performed by team members training in those workflows. • Assist with data QC to ensure accuracy and alignment across multiple systems (OnCore, Epic, Zendesk, CTO Database, etc.).

MINIMUM QUALIFICATIONS • A Bachelor’s degree in science, business, healthcare administration or related field and at least three years’ related experience or equivalent combination of experience and education.

Additional requirements: • Ability to make positive contributions and work effectively and efficiently in a group environment. • Exceptional customer service skills. • Strong written and oral presentation skills. • Ability to communicate effectively with all levels of staff, faculty, management and collaborators. • Ability to effectively prioritize and organize work independently in a fast-paced, high-volume setting. • Ability to work effectively and efficiently in a group environment. • Demonstrated skill in using Microsoft Word, Excel, and Access.

Equivalent education and/or experience may substitute for minimum requirements. DESIRED QUALIFICATIONS • Experience working in OnCore or other CTMS system. • Experience working with an Customer Service Management (CSM) ticketing system tool, such as Zendesk. • Familiarity with electronic medical records and healthcare business systems. Experience working with web-based solutions. • Experience in academic health system operations or medical setting.

CONDITIONS OF EMPLOYMENT The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.

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University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.