DESCRIPTION

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 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).

In conjunction with, and at the direction of, the Clinical Research Supervisor, incumbent will assist in coordinating and overseeing start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. May create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator may plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and help to coordinate operational efforts, assure compliance with state and federal regulatory guidelines, oversee the quality of the medical and clinical research data, provide direction and guidance to investigators, provide education and information to the general public concerning the ongoing clinical trials, assist PIs with proposals, progress reports and manuscripts, independently create original documents and policies for assigned disease teams, work closely with federal and state regulatory officials when/if indicated. The CRC will serve as a lead coordinator for team members, providing training at the direction of the Clinical Research Supervisor. Other duties assigned as needed.

MINIMUM QUALIFICATIONS

• Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

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

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

• Strong knowledge of investigational protocols especially with NAFLD, NASH, and/or Cirrhosis protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

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