Clinical Research Operations Specialist

Job Description

Qualifications

• •Education and Experience: Bachelor’s Degree in Healthcare Administration, Finance, or account required
• •Minimum two years experience in clinical research finance, budget development or contract negotiation required
• •Knowledge and Skills: Knowledge of clinical trial practices, billing compliance regulation, Medical coverage analysis, and medical terminology
• •Familiarity with budgeting for cell therapy studies
• •Experience with early phase or complex trial designs
• •Knowledge of fair market value standards and budgeting practices for high-cost research procedures
• •Working knowledge of CPT codes, RVUs, and Medicare billing practices in clinical research
• •Read, write legibly, and speak in English with professional quality; use computer, printer, and software programs necessary to the position (e.g., Word, Excel, Outlook, PowerPoint)
• •Operate/troubleshoot basic office equipment required for the position
• •Relate and communicate positively, effectively, and professionally with others; work calmly and respond courteously when under pressure; collaborate and accept direction
• •Think critically; manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solve; recall information with accuracy; pay close attention to detail; work independently with minimal supervision
• •Distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position
• •Licensures and Certifications: None

Benefits

Responsibilities

• •The Clinical Research Operations Specialist participates in the start-up activities related to opening new trials, including performing financial feasibility assessments, and will work closely with the Principal Investigator, study start-up team and Research Affairs Financial Management to ensure accurate and compliant budget development and negotiation
• •Develops the Medicare Coverage Analysis to begin budget development
• •Creates new studies in the OnCore Clinical Trial Management System and tract contract milestones and EPIC to support charge review and research billing compliance
• •The Clinical Research Operations Specialist develops and negotiates budgets for clinical trials working with sponsors, ancillary departments, and billing offices
• •This position requires the ability to interpret study protocols, identify billable vs research-only procedures and ensure alignment between clinical activities and financial workflows
• •Facilitates and processes financial transactions for clinical trial accounts
• •Performs other duties as needed