Assistant Clinical Research Coordinator - 140861

As the largest and oldest department within the UC San Diego School of Medicine, the Department of Medicine employs nearly 500 faculty members and 1,000 academic appointees, residents, fellows, postdocs, and staff, in pursuit of its academic, clinical, and research missions.

The Division of Gastroenterology and Hepatology in the Department of Medicine conducts research studies which study Metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated steatotic liver disease (MASLD) in adult patients.

The MASLD Research Center focus on the etiology, contributing factors, natural history, complications, and therapy of MASH and MASLD. The MASLD Research Center participates in pharmaceutical clinical trials and Principal Investigator (PI) initiated studies which focus on the discovery and validation of innovative biomarkers for MASLD, with a special focus on identifying those patients at greatest risk for MASH, advanced liver fibrosis, and hepatocellular carcinoma (HCC).

In conjunction with and under full supervision of the Clinical Research Supervisor, incumbent will coordinate and assist with oversight of start-up procedures, recruitment, screening, enrollment, and maintenance of subjects. The Assistant Clinical Research Coordinator will assist operations, assure compliance with state and federal regulatory guidelines, assist with oversight of the quality of the medical and clinical research data, and directly communicate with assigned physicians. They will serve as a resource to the investigators to interpret, educate and inform concerning the ongoing clinical trials, assist PIs with proposals, progress reports and manuscripts, assist with creating original documents and policies for assigned disease teams, work closely with federal and state regulatory officials when/if indicated.

At the direction of the Clinical Research Supervisor, the Assistant Clinical Research Coordinator may: provide training, data and chart management, quality assurance check for studies, provide backup to research center activities. Other duties assigned as needed.

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

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

• Experience with clinical trials participant or study subject recruitment.

• Experience with external clinics for educational and recruitment efforts.

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

• 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 working with FDA policies regulating clinical trials.

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

• 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 coordinating study startup activities.

• 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.

• Ability to speak Spanish.

• Knowledge of MASLD research studies.

• Occasional evenings and weekends may be required.

• 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.

• Employment is subject to a criminal background check and pre-employment physical.