Current UC San Diego Health Neuroscience employees who apply by 09/18/2024 will have priority consideration for this position. Recruiters will refer qualified internal candidates after the first 7 days of the job posting. All qualified external applicants and additional internal applicants who apply after the priority date may have further consideration pending the results of the initial review.

Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. This entails collecting, entering, and ensuring timely reporting of all required data and maintaining accurate and complete clinical research files and patient source binders.

Knowledge of the UCSD Kuali system for Human subject's submissions including consent form development and modification, renewals, and safety reports is required. Must be able to directly communicate with assigned physicians, sponsors and contract research organizations, as well as patient support organizations. study subjects and their families. Must be fluent in Spanish and English in order to interact with both English and Spanish speaking research subjects and their families. Able to work with pediatric and adult research subjects. Experience with the unique multisystem problems and genetic causes of mitochondrial disease and Rett syndrome. In particular knowledge of Leigh syndrome and experience with patient evaluation and database entry for an ongoing longitudinal study on this severe mitochondrial disease. Experience with the North American Mitochondrial Disease Consortium database and entry of patient data. Familiarity with Epic EMR systems and the systems required by the UCSD ACTRI to set up and run clinical trials. Ability to take the lead in coordinating a rare disorder study including clinical testing of patients. Experience with organizing genetic testing on mitochondrial disease patients and study subjects including obtaining insurance authorization when needed. The successful candidate must be able to identify and recruit subjects and be able to screen patients for eligibility by interpreting medical charts for required criteria.

Attend twice weekly team meetings. Provide direct assistance to the Principal Investigator and Co-Investigators for industry and NIH sponsored studies as well as investigator-initiated studies. Experience with the UCSD Oracle accounting system, ability to review and verify university research account statements, professional fee statements, and invoicing.

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.

• Experience with natural history and familiarity with rare mitochondrial disease and related genetic white matter disorders.

• Experience performing clinical research duties in a clinical research environment.

• Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.

• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

• Experience working with FDA policies regulating clinical trials.

• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.

• Experience interpreting medical charts, experience in abstracting data from medical records.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

• Experience with clinical trials participant or study subject recruitment.

• Experience coordinating study startup activities.

• Experience providing in-service training to various research personnel on protocols, processes, and procedures.

• Knowledge of x-rays, scans, and other diagnostic procedures.

• Experience maintaining files and keeping records.

• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.

• Ability to work independently. Ability to maintain confidentiality.

• Experience completing clinical trials case report forms via hard copy and online.

• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

• Certification as a Clinical Research Associate or Coordinator.

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Job offer is contingent upon satisfactory clearance based on Background Check results.

• Occasional evenings and weekends may be required.