Clinical Research Operations Specialist -Temporary

Loma Linda University Health • Loma Linda, CA

19h

About The Position

The Clinical Research Operations Specialist for the Cancer Center Clinical Trials Unit (CCCTU) plays a critical role in the financial management of clinical research trials from study startup to study closure. 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.

Requirements

• 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 of clinical trial practices, billing compliance regulation, Medical coverage analysis, and medical terminology.
• 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.

Nice To Haves

• Experience with oncology clinical trials at an academic medical center or cancer research institution preferred.
• 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.

Responsibilities

• Performs financial feasibility assessments
• Works 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.
• Develops and negotiates budgets for clinical trials working with sponsors, ancillary departments, and billing offices.
• Interprets 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees