UCSD Layoff from Career Appointment: Apply by 04/09/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 04/21/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Division of Gastroenterology in the Department of Medicine conducts research studies which study Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD) in adult patients. The Non-Alcoholic Steatohepatitis Clinical Research Network (NASHCRN) is a multi-center study funded by NIH and is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to focus on the etiology, contributing factors, natural history, complications, and therapy of NASH and NAFLD. UCSD is one of eight sites nationwide associated with this study.
In addition, the NAFLD Research Center participates in pharmaceutical clinical trials and Principal Investigator (PI) initiated studies which focus on the discovery and validation of innovative biomarkers for NAFLD, with a special focus on identifying those patients at greatest risk for nonalcoholic steatohepatitis (NASH), advanced liver fibrosis, and hepatocellular carcinoma (HCC).
Reporting directly to the Clinical Research Supervisor.Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including creating study specific source documents, 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. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards (where applicable). Provide direct assistance to the Supervisor in reviewing and verifying 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.
Demonstrated 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.
Demonstrated 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.
Proven 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.
Thorough knowledge of x-rays, scans, and other diagnostic procedures.
Strong 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.
Experience completing clinical trials case report forms via hard copy and online.
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.
Employment is subject to a criminal background check and pre-employment physical.
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