Clinical Research Coordinator, GI Division

University of California, San Francisco

About the Role

The Clinical Research Coordinator (CRC) will join the GI Division and responsibilities will include coordination of clinical research studies related to liver disease and liver transplantation. The CRC 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 project, providing HCV screening and low-threshold standard of care HCV treatment on a mobile van at various locations in San Francisco.

Key Responsibilities

• Coordinate the tasks of multiple clinical research studies.
• Act as an intermediary between services and departments, 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 and assist with training of Assistant CRCs.
• Assist PI supervisor with oversight of other research staff.
• Manage Investigator’s protocols in the Committee on Human Research (CHR) online system, including 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 and 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 internal and external audits or reviews of study protocols.
• Perform other duties as assigned.
• Perform fingersticks for rapid HCV antibody testing and/or HCV RNA.
• Perform venipuncture for HCV RNA confirmatory testing and other labs.
• Drive the van for outreach shifts and vehicle maintenance services.
• Consenting participants.
• Extracting information from medical records.
• Completing case report forms, data collection, and data entry.

Requirements & Tech Stack

• Experience in research with “hard-to-reach” and vulnerable populations.
• Knowledge of resources for HCV and HIV prevention and education.
• Knowledge of drug abuse prevention and treatment.
• Knowledge of street and community-based outreach methods.
• Phlebotomy certification is preferred, but not required.
• Experience performing phlebotomy with people experiencing homelessness and people who inject drugs is preferable.
• California Driver's License.
• High School Diploma; 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.
• Ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently.
• Ability to complete projects in a timely manner.
• Ability to prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols.
• 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 HIPAA regulations, UCSF mission statement and purpose for research, and patient safety and confidentiality policies.
• Knowledge of medical terminology.
• Knowledge of research policies and guidelines.
• Knowledge of guidelines for packing/shipping infectious substances.
• Knowledge of database building/analysis.
• Knowledge of data management within some of the following: Access, Stata, SASS/ SPSS, Teleform.
• 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.

Qualifications

• California Driver's License
• Driving is a core function of the job.
• Essential tasks of the role cannot be performed adequately without driving.
• Use of a university vehicle will be required.
• Position will be required to drive frequently (more than 10 hours/month).
• Position will be required to drive outside of city or county limits.
• Will need to register with the California Pull Program.

Preferred Qualifications:

• BA or BS in physical or biological sciences and one year of clinical research experience.