Clinical Research Coordinator Gastroenterology

The GI Division Clinical Research Coordinator will support clinical research studies centered on liver disease and liver transplantation. This position functions at a fully proficient, journey-level capacity, with responsibility for independently managing, executing, and coordinating research protocols under the direction of the Principal Investigator (PI). The coordinator may also oversee data collection and study operations for multiple simultaneous clinical research projects, ensuring compliance with established protocols, UCSF policies, and regulatory requirements.

Duties may include, management and coordinating the tasks of multiple clinical research studies, act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist PI supervisor with oversight of other research staff; manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

Required Qualifications ▪ High School Diploma efficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training ▪ Attention to detail; strong interpersonal skills; excellent verbal and written communication skills to effectively coordinate with subjects, team members, other departments, and external institutions; and the ability to multitask in a fast-paced environment while working with a diverse subject population ▪ Ability to work independently, complete projects in a timely manner, and prioritize multiple assignments to ensure essential tasks are completed by deadlines Preferred Qualifications ▪ BA/BS degree in physical or biological sciences ▪ One year of clinical research experience, or a combination of education and experience ▪ Fluency in the use of the Committee on Human Research (CHR) iMEDRIS system for submission, renewal, and modification of protocols ▪ Understanding of patient populations to build rapport and assess appropriate and realistic participation in research studies ▪ Experience with electronic medical records ▪ Knowledge of UCSF and departmental policies related to reimbursement, research guidelines, confidentiality, and HIPAA regulations, as well as patient safety and confidentiality practices (electronic and hard copy records, patient charts, and communications) ▪ Knowledge of medical terminology, research policies and guidelines, shipping requirements for infectious substances, database development and analysis, and data management using tools such as Access, Stata, SAS/SPSS, and TeleForm ▪ Experience applying regulations and guidelines, including:  ▪ Good Clinical Practice (GCP)  ▪ Health Insurance Portability and Accountability Act (HIPAA)  ▪ Protection of Human Research Subjects  ▪ CHR regulations for recruitment and consent of research subjects  ▪ Effective cash handling procedures  ▪ Environmental Health and Safety (EHS)  ▪ Fire Safety Training