The UCSD Center for Esophageal Diseases provides leading care for esophageal conditions including achalasia, complex GERD conditions, eosinophilic esophagitis, Barrett's esophagus, esophageal cancer, and disorders of brain-gut interaction. The UCSD Center for Esophageal Diseases is within the Division of Gastroenterology in the Department of Medicine. The center is comprised of a state-of-the-art motility laboratory, nationally and internationally regarded faculty with diverse clinical expertise and research programs, and robust interdisciplinary relationships. The UCSD Center for Esophageal Diseases is the leading tertiary referral center for complex esophageal motility patients in the Southern California region. The UCSD Center for Esophageal Diseases research program houses a biorepository, registry, clinical trials & outcomes unit, and wet lab with active projects funded by diverse sponsors including the NIH & VA. The core mission of this program is to perform high quality patient oriented clinical research in order to advance the field of esophageal disorders.

Under supervision, incumbent will independently coordinate clinical research activities in the UCSD Center for Esophageal Diseases. Responsibilities will include oversight of investigator initiated and sponsored studies and coordination of startup procedures, study implementation, subject recruitment, screening, and enrollment, and follow-up of subjects in multiple studies within the program. Incumbent will be responsible for creating informational and recruitment materials, overseeing the project budget, and day-to-day patient activities. In addition, incumbent will act as a liaison with other UCSD departments and community clinics/agencies for the purposes of implementation of these studies, and may have added responsibilities of training others.

Reporting to the Principal Investigator and Esophageal Clinical Research Coordinator, the Assistant Clinical Research Coordinator is 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. Other duties assigned as needed.

• 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 performing clinical research duties in a clinical research environment.

• Experience with clinical trials participant or study subject recruitment.

• Excellent 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 interpreting medical charts, experience in abstracting data from medical records.

• Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Access, Excel and MS Word.

• 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 coordinating study startup activities.

• Experience maintaining files and keeping records.

• Ability to work independently. Ability to maintain confidentiality.

• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

• Experience with external clinics for educational and recruitment efforts

• Certification as a Clinical Research Associate or Coordinator.

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Experience working with FDA policies regulating clinical trials.

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

• 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.

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

• Occasional evenings and weekends may be required.

• Spanish speaking preferred.