Clinical Research Coordinator - Medicine - 140230

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

• Strong theoretical knowledge as typically attained by a 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.

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

• 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.

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

• 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.

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

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

• 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.

• Working knowledge of medical and scientific terminology.

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Excellent interpersonal, as well as written and verbal 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. Excellent phone etiquette skills.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• Possess a Clinical Research Coordinator Certificate or Master's Degree.

• Experience coordinating and conducting clinical trials, observational and treatment research trials, in MASLD.

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

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

• Occasional evenings and weekends may be required.

• Must be able to work various hours and locations based on business needs.