Clinical Trial Coverage Analyst - Hybrid - 130621

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.

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

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UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20
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UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.