Sr. Clinical Trial Coverage Analyst-VC-Health Sci. - 139611

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.

The Sr. Clinical Trial Coverage Analyst (SCA) will have full understanding of a clinical trial protocol and related regulatory documents in order to prepare clear documentation of who the payor will be for all medical procedures and services required in a clinical research project. The SCA determines whether proposed clinical projects are a qualifying clinical trial as defined by CMS' Medicare Clinical Trial Policy and determines what is billable after reviewing the Medicare Benefits Policy manual, relevant National Coverage Decisions (NCDs) and Local Coverage Decisions (LCDs), Code of Federal Regulations (CFRs), state laws, and when necessary, consulting with the Medicare Administrative Contractor (MAC) for this region.

The SCA will perform coverage analyses that include the development of the coverage analysis (CA) grid and billing justifications of varying complexity with information provided by the Principal Investigators, Study Teams, and other departments (i.e. HRPP, OCTA, and OCGA) in compliance with UCSD policies. The SCA must be extremely comfortable working with numerous databases and electronic information, able to quickly read and comprehend large amounts of scientific, medical, and legal text. The coordinator will have initiative, use good judgement and tact, interact with various internal and external customers with ease, and be highly resourceful and motivated in resolving clinical project issues in order to fulfill campus objectives. Candidates should have clinical research finance experience (e.g. clinical study budget development and negotiation experience), a strong understanding of protocol design and conduct, as well as an understanding of applicable federal, state and local clinical research billing laws, regulations and policy.

The incumbent is an experienced professional who knows how to apply theory and put it into practice with in-depth understanding of the professional field; independently performs the full range of responsibilities within the function; possesses broad job knowledge; analyzes problems / issues of diverse scope and determines solutions. May conduct special projects as assigned by a Supervisor. Performs other duties as assigned.

Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and / or compromise the institution's assurance of regulatory compliance with the federal government.

• Seven (7) year's of related experience or a Bachelor's degree in a related area plus three (3) years of relevant experience.

• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.

• Demonstrated ability to manage a high volume workload, multitask and meet rigid deadlines. Ability to work independently and quickly with self-motivation and good judgment. Ability to handle multiple projects and tasks simultaneously. Possess strong organizational and analytical skills with attention to detail.

• Demonstrated self-discipline and sound, independent judgment completing complex assignments. Demonstrated excellence in reliability and attendance.

• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. Ability to rapidly research online resources for information supporting billing rules and regulations. Ability to quickly read and comprehend large amounts of electronic text comprised of scientific, medical and legal language. Strong problem-solving and decision making skills.

• Demonstrated proficiency in public speaking, and writing. Proven ability to communicate effectively and participate in multidisciplinary discussions regarding the health sciences campus research process and related details to a wide audience (scientists, physicians, nurses, staff, sponsors, and the general public.)

• Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.

• Excellent interpersonal skills including tact, diplomacy, flexibility and professionalism in dealing with faculty, staff and industry representatives. Excellent communication skills both verbal and written.

• Ability to maintain professional manner in short-fuse and time-sensitive situations.

• Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, UC system units, and sponsoring agencies and companies.

• Ability to be flexible and adapt within an ever-changing, dynamic, service-oriented environment and operate effectively within a team. Ability to effectively collaborate with multiple departments.

• Advanced skills in using software applications such as Microsoft Excel, Microsoft Word, Microsoft PowerPoint, database applications, and internet search engines. Ability to learn new systems with ease.

• Experience working with faculty, administrators, and staff in an academic medical center, health care or university environment.

• Demonstrated expertise in coverage analysis, protocol assessment, IRB submission, or clinical trials budgeting/negotiation and/or industry contracting.

• Knowledge of research regulatory requirements (including FDA and other federal and state regulations, such as SB 37 and NCD 310.1), GCP/ICH guidelines, and special requirements for drug and medical device trials, as well as ICD and CPT coding and clinical research billing modifiers. Knowledge of regulatory, financial and administrative requirements of third party billing for clinical care or research.

• 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.