Clinical Research Coordinator - GI Division

Job Description

The Clinical Research Coordinator (CRC) will join the GI Division and responsibilities will include coordination of clinical research studies related liver disease and liver transplantation. The Clinical Research Coordinator will perform independently at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. The CRC will work on the DeLIVER Care, provides HCV screening and low-threshold standard of care HCV treatment on at various locations in San Francisco on a mobile van.

CRC's 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.

The CRC will also be responsible for performing fingersticks for rapid HCV antibody testing and/or HCV RNA, venipuncture for HCV RNA confirmatory testing and other labs, driving the van, and completing research activities such as consenting participants, extracting information from medical records, completing case report forms, data collection, and data entry. The CRC is required to be experienced in research with "hard-to-reach" and vulnerable populations, knowledge of resources for HCV and HIV prevention and education, drug abuse prevention and treatment, and street and community-based outreach methods. Phlebotomy certification is preferred, but not required. Having experience performing phlebotomy with people experiencing homelessness and people who inject drugs is preferable.

Qualifications

Required Qualifications: - California Driver's License - High Schol Diplima; or equivalent experience/training - Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population - Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines Preferred Qualifications: - BA or BS in physical or biological sciences and one year of clinical research experience - Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system - Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation - Experience with electronic medical records - Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms - Experience applying the following regulations and guidelines: - Good Clinical Practice Guidelines - Health Information and Accountability Act (HIPAA) - The Protection of Human Research Subjects - CHR regulations for recruitment and consent of research subjects - Effective Cash Handling Procedures - Environmental Health and Safety Training - Fire Safety Training - Experience working with programs serving people experiencing homelessness and/or substance dependence License/Certifications: - California Driver's License - Does the job demonstrably require driving as a core function? Yes - Can the essential tasks of the role be performed adequately without driving? No- the CRC will be responsible for driving the van to and from outreach shifts and vehicle maintenance services - If driving is required, would using alternative transportation (like public transit, carpooling) significantly impact the employee's ability to perform job duties in terms of time and cost to the employer? Yes - If required to drive, will use of a university vehicle be required? Yes - Will use of a personal vehicle be required? No - Will the position be required to drive frequently (more than 10 hours month)? Yes - Will position be required to drive outside of city or county limits? Yes - Will position need to register with the California Pull Program? Yes