Clinical Trial Coverage Analyst, VC-Health Science - 139608

Candidates hired into this position will have the ability to work remotely.

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.

The incumbent applies acquired job skills, policies, and procedures to complete substantive assignments / projects / tasks of moderate scope and complexity; exercises judgment within defined guidelines and practices to determine appropriate action.

Using research compliance concepts, applies organization policies and procedures to review and / or pre-review moderately complex, minimal risk research protocols. Works independently in most cases without a great deal of supervision or oversight for routine or standard assignments. Occasionally pre-reviews or highlights potential issues of concern for department heads or committee members to consider in their review of research protocols that qualify for full review.

• Six (6) years of experience or a Bachelor's degree in a related area plus two (2) 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.

• 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.

• Independence, planning and decision-making abilities to complete assigned duties.

• 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.

• Time management skills and the flexibility to accommodate changing priorities in unit.

• 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.

• Excellent customer service skills, pleasant, helpful and patient.

• 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).

• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check.
• Employment is subject to pre-employment physical for those who work in clinical settings and/or with patients.
• Performs other duties as assigned.
• Complies with all policies and standards.
• Complies with the University of California, San Diego Health (UCSDH) Principles of Community.
• This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.