UCSD's Office of Coverage Analysis Administration (OCAA) is dedicated to ensuring billing compliance for clinical research. A coverage analysis harmonizes the clinical trials protocol, budget, contract and informed consent to determine what is billable to insurance based on federal/state billing regulations including Medicare's National Coverage Decision (NCD) 310.1 as well as other third-party billing rules. It ensures consistent application of Medicare rules across studies, and consistent application of study documents. The office works with other key offices, including the Human Research Protection Program and the Office of Clinical Trials Administration to assure harmonization of regulatory and budgetary processes in clinical trials.

Under general supervision, responsible for reviewing clinical research trials to determine if they are qualified clinical trials pursuant to Medicare's National Coverage Determination 310.1 (NCD). The incumbent creates a coverage analysis based on clinical trial protocols and related regulatory documents that outlines the billing of the clinical items and services required by the research study. The incumbent will independently and effectively communicate the results of the coverage analysis to the Principal Investigator and/or the study team. Output from this position may be reviewed and audited by the OCAA management team. Completes other duties as assigned.

• Six years of related experience, education/training, OR a Bachelor's degree in related area plus two years of related experience/training.

• Ability to interpret research contracts, study budgets, clinical protocols, and consent forms to extrapolate billing/coverage data.

• Proficiency with Medical Terminology.

• Effective, efficient and tactful oral and written communication skills.

• Knowledge of clinical research including the conduct of commercial, federal and PI initiated protocols. Demonstrated experience working with clinical trials research activities, regulatory compliance, guidelines related to IRB informed consent, as well as interpreting and comprehending complex clinical research protocols, activities and guidelines.

• Knowledge of relevant Federal and State regulations, and policies.

• Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.

• Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.

• Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.

• Strong organizational skills, the ability to multi-task, and work with frequent interruptions. Demonstrated ability to manage a high volume workload and meet deadlines. Demonstrated resourcefulness and attention to detail.

• Nursing Degree or Healthcare Professional experience.

• Knowledge of Medicare coverage decisions, benefit policy manuals and billing processes. Knowledge of FDA and Medicare regulations related to clinical trials including trials involving Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).

• Employment is subject to a criminal background check.

• Must be willing to work occasional overtime and travel to sites as necessary.