Research - Laboratory/Non-Laboratory, Staff/Administrative
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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.
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.
Thorough knowledge of x-rays, scans, and other diagnostic procedures.
Demonstrated experience maintaining files and keeping records. Experience interpreting medical charts, experience in abstracting data from medical records.
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.
Proven ability to interact effectively with diverse groups, including professional and non-professional staff and clients.
Strong planning and organizational skills. Ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately. Ability to work independently. Ability to maintain confidentiality.
Certification as a Clinical Research Associate or Coordinator.
Experience working with research bulk accounts.
Experience with investigational drug authorization criteria.
Experience performing clinical research duties in a clinical research environment.
Experience working with FDA policies regulating clinical trials.
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 with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Experience providing in-service training to various research personnel on protocols, processes, and procedures.
Experience completing clinical trials case report forms via hard co
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