The Clinical Trials Financial Analyst II role providescoverage analysis, budget,startup& post awardsupport forindustry sponsoredclinical trialsandInvestigator InitiatedTrials.The analyst is part of theFred Hutch, University of Washington, and Seattle Childrens Cancer Consortiums (Consortiums) central clinical trials office, Clinical Research Support (CRS).

Actively works onpre-awardactivities includingclinical trialfeasibilitybudgets, detailedstudybudgets, coverage analysis development, calendar/billing gridreviews, completingaccountregistrations, navigating the budget through theConsortiumssystems,negotiating amendments as neededandpost award activities includingmanaging study financials through the lifecycle of the study. Works independently and in cooperation with internal and external stakeholders andmaintainsprofessionalrelationshipswith faculty, study teams, and sponsors.

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

• Partner with clinical trial staff, central regulatory operations team, and consortium study teams to communicate start-up process, milestones, and timeline goals.
• 0Perform formal review of study documentation and Medicare billing rules todeterminewhich items and services performed as a part of a clinical research study may be billed to insurance, and which items must be paid for by the study account (or sponsor)
• Identify research costs and develop comprehensive budgets for single & multi-site industry sponsored clinical trials and Investigator Initiated Trials (IITs)
• Develop & maintain standard templates for clinical trial budget development and post award management
• Prepare, submit, and manage study startup documentation across multiple platforms, including the OnCore CTMS, REDCap system, and email
• Perform review of initial & final budget, contract, including payment terms, ICF, and Billing Grid to confirm document congruence in compliance with applicable state and federal billing, coding, and reimbursement related statutes, regulations, guidance and accreditation standards.
• Prepare, submit, and manage financial document updates across multiple platforms (e.g., OnCore CTMS, REDCap, and email) that result from protocol amendments and/or other changes as needed
• Monitor and track monthly labor and non-labor spending for allocation of appropriate costs to Sponsored projects, grants and discretionary funds.
• Monitor financial performance relative to budget and explain variances and trends.
• Provide Budget-to-actual financial reporting and implement upstream process improvements in pre-award based on post award learnings.
• Assist with ongoing financial analysis, forecasting, and ad-hoc financial models.
• Work professionally and proactively with central offices, clinic partners, faculty members, and research collaborators in support of the overall research plan.

MINIMUM QUALIFICATIONS:

• Bachelors degree in accounting or finance required, or equivalent combination of education and experience.
• Minimum of two years of experience in finance, preferable in Phase I-III clinical trials.
• Must have previous experience developing complex, multi-phase clinical trial budgets, negotiating study budgets, revisions and knowledge of medical terminology.
• Working knowledge of financial information and related operational statistics.
• Ability to develop and perform complex calculations in Microsoft Excel.
• Strong analytical skills with attention to detail.
• Well-developed verbal and written communication skills, including an ability to understand complex problems, to collaborate and explore alternative solutions. Ability to organize thoughts and ideas into understandable terminology.
• Ability to work independently on multiple projects and communicate status of projects to key decision makers on a proactive basis.
• Exposure to grant accounting or project cost accounting a plus.

PREFERRED QUALIFICATIONS:

• Clinical research related certification preferred.
• Demonstrated familiarity with process improvement principles.
• Demonstrated familiarity with project management tools and techniques.
• Experience performing clinical trial management/administration and/or sponsor invoicing activities utilizing OnCore or another CTMS system.
• Experience performing or reviewing clinical trial management/administration activities utilizing EPIC or another patient billing and registration system.

The annual base salary range for this position is from $80,475 to $120,682, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.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), and paid parental leave (up to 4 weeks).