This is a contract position with the possibility of extension/career conversion.
Special Selection Applicants: Apply by 08/20/19. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Depending on the experience of the selected candidate, this position will be hired at the Research Compliance Analyst 2 or Research Compliance Analyst 3 level.
RNs, LVNs and other clinical professionals are encouraged to apply!
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, this position is 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.
Bachelor's Degree in related area; and/or equivalent experience/training.
A minimum of two (2+) or more years of relevant experience.
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. Excellent customer service skills, pleasant, helpful and patient.
Solid knowledge of clinical research including the conduct of commercial, federal and PI initiated protocols. Demonstrated knowledge of relevant Federal and State regulations, and policies.
Proven 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.
Proficiency with computers, including ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
Strong organizational skills, ability to multitask, and work with frequent interruptions. Ability to manage a high volume workload and meet deadlines. 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 able to work occasional overtime and travel to sites as necessary.
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.