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#97534 Clinical Trial Protocol Specialist

Filing Deadline: Tue 5/28/2019

This position is a contract position with the possibility of extension/career conversion.

Special Selection Applicants: Apply by 01/28/19. Eligible Special Selection clients should contact their Disability Counselor for assistance.


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 of the Director and Manager, the incumbent will utilize research compliance professional concepts to support the coverage analysis development process. The incumbent will review clinical trial protocols submitted to the Office of Coverage Analysis Administration (OCAA), and identify key procedures required by the protocol and associated study documents, creating a procedure grid.

This procedure grid enables the study team and others to then properly budget and assign financial responsibility to the study sponsor, patient insurance, or department. The individual will work closely with OCAA Coverage Analysts in developing the procedure grid. This position maintains compliance for clinical research billing by developing a precise and comprehensive procedure grid which captures all of the study protocol's events and time points, along with recording accurate citations from the study documents to support the inclusion of each item. Performs other duties as assigned.

Uses research compliance professional concepts to support protocol submission process. Reviews and/or pre-reviews minimal risk, expedited or standard procedure research protocols. Applies defined policies and procedures to categorize or analyze departmental issues.


  • A Bachelor's degree in related area; and/or equivalent experience/training.

  • Human subjects, and animal care and use: academic training in the biological or social sciences, humanities or bioethics. Theoretical knowledge of human subjects research and related research areas.

  • Attention to detail. Ability to keep and maintain records in a neat and orderly fashion, and perform administrative duties with a high level of proficiency and competency.

  • Ability to read and comprehend complex materials. Ability to interpret and disseminate information on a wide variety of complex policies from various organizations.

  • Excellent writing and oral communication skills (clarity, sentence/paragraph construction and grammar, et cetera). Skill in proofreading, editing and use of reference sources in order to type and process material.

  • Knowledge of MS Office software. Advanced computer skills on internet, email, Word, Excel and Windows programs. Efficient and accurate data entry and typing skills.

  • Basic knowledge of relevant federal, state, organizational and system policies.

  • Possession of excellent customer service for internal and external customers. Ability to maintain professional manner in short-fuse and time-sensitive situations.

  • Demonstrated ability and desire to learn; curiosity around the research activities in which they are involved.

  • Skills in problem solving, multi-tasking, working with frequent interruptions, and an effective listener. Organizational skills to prioritize multiple tasks, develop, analyze and/or revise procedures, meet deadlines, heavy pressures and changing priorities.


  • Ability to use independent judgment and initiative to accomplish tasks.
  • Experience with medical or biological terms.
  • Knowledge and experience to apply introductory budget and billing principles during review of research protocols.


  • Employment is subject to a criminal background check.
  • Occasional overtime may be required.

UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic 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.


UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego School of Medicine
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Commensurate with Experience
East Campus
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Work Schedule:
Days, 8 hrs/day, Monday-Friday


As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.