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

It participates in the Non-Alcoholic Steatohepatitis Clinical Research Network (NASHCRN), a multi-center study that focuses on the etiology, contributing factors, natural history, complications, and therapy of MASH and MASLD.

In addition, the MASLD Research Center participates in pharmaceutical clinical trials and Investigator 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).

The other areas of research include cirrhosis, obesity, diabetes and metabolic diseases.

The Clinical Research Coordinator Assistant will be assigned to assist in coordinating industry-sponsored and PI-initiated research studies involving human subjects that are being conducted in the MASLD research center. Assist with initiation, implementation and management of research studies. Ensure compliance with goals and objectives of research protocols and with state and federal regulatory guidelines.

Under supervision, duties will include but not limited to: interpreting research protocols; recruiting subjects; screening for eligibility including scheduling subjects' visits; coordinating clinical, laboratory and data collection activities; processing and submitting laboratory specimens; collecting and entering research data; maintaining accurate and complete clinical research files and patient medical charts. Update study and patient records in the University approved Clinical Trial Management System (VELOS) on a consistent basis. Provide direct assistance in reviewing project milestones.

Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Assist PIs with proposals, progress reports and manuscripts. Work closely with federal and state regulatory officials.

Incumbent will also assist in maintaining the biorepository which supports processing, maintenance and storage of the biospecimens. Assist in completion Data Use agreements/material transfer agreements for exchange of biospecimens, research or metadata between UCSD and outside collaborators. Other duties assigned as needed.

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences and/or Bachelor's degree, and/or an equivalent combination of education and experience.

• Experience performing clinical research duties in a clinical research environment. Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.

• Experience creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor requirements.

• Experience in medical assessment, patient interviewing, and interpreting laboratory procedures and values to determine toxicities and patient eligibility related to protocol management.

• Experience interpreting medical charts, experience in abstracting data from medical records in relation to study subject screening.

• Proven ability to determine sources of information and data, and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.

• Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.

• Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.

• Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.

• Excellent interpersonal, as well as written and oral communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts.

• Experience with editing, including summarizing information into concise and condense documents.

• Skill in working independently and following through on assignments with minimal supervision. Good judgement to know when to ask for assistance from supervisor in cases where regulations and policies & procedures are not clear.

• Demonstrated ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.

• Demonstrated knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.

• Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and procedures.

• Must be able to maintain strict confidentiality.

• Must be available to work occasional evenings and weekends.

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