Clinical Research Coordinator

About the role

The Clinical Research Coordinator (CRC) will provide research coordination for the UCSF ID Clinical Research Center (SF IDRC), within the HIV, Infectious Diseases and Global Medicine (HIVIDGM) Division. Our unit conducts new and ongoing clinical trials focused on several infectious diseases, including HIV, COVID-19, viral hepatitis, sexually transmitted infections and monkeypox.

Responsibilities

• Identify, interview, and (depending on type of study) consent participants, and assist clinical staff with study follow-up visits for 1-5 outpatient observational and/or treatment studies as assigned by the investigator and unit manager.
• Perform community outreach at appropriate sites in San Francisco and potentially in other locations in the Bay Area.
• Pre-screen potential participants (ask about current health conditions, medications, etc.) for clinical staff to be able to assess participant for advancement through the screening process.
• Coordinate screening and on-study visits with nursing staff, assist with obtaining vital signs and collecting biological samples as necessary and within scope of practice/training.
• Administer questionnaires, train participants on proper data and specimen collection techniques where appropriate.
• Establish rapport with subjects, respond to their diverse needs, and become their intermediary between physicians and other departments (i.e. assist with care coordination).
• Communicate with Principal Investigator and/or unit manager regarding study and participant progress, notify unit leadership when problems or questions require a physician’s involvement.
• Develop and maintain complex schedules for subjects enrolled in multiple studies.
• Develop and maintain complex schedules for participants enrolled in multiple studies.
• Develop, prepare and maintain study documents, subject files, and databases.
• Prepare complex laboratory setups and paperwork for specimen collection and tracking.
• With training, perform centrifugation and aliquoting of blood and other biological samples or transport samples to processing laboratory for complex processing using IATA/Safe Shipping guidelines for biohazardous samples.
• Maintain collection of blood, STD self-swabs, rectal swabs, nasopharyngeal swabs, stool collection and aliquoting (when indicated) and ensure appropriate processing.
• Transport/ship specimens and paperwork to appropriate laboratories.
• Package and ship diagnostic specimens, coordinate complex shipping requests with multiple labs including using multiple carriers for both domestic and international shipments, and shipping samples in liquid nitrogen.
• Ensure all procedures, laboratory tests, and required data are collected at each visit; coordinate follow-up; and complete documentation.
• Coordinate care with primary provider and communicate regarding study participation, receipt of study provided medications, and any significant adverse events of which the provider/care team should be aware.
• Provide back-up coverage for other CRCs in implementing clinical research protocols nested within the research unit.
• Coverage of other CRCs in implementing clinical research protocols nested within the research unit.
• Coordinate with teams to ensure correct specimens are collected according to protocol at the time of study procedures, which may include but are not limited to leukapheresis, electroporation, liver biopsy, gut biopsy, endoscopy, radiologic imaging, and lumbar puncture.
• Coordinate with the leukapheresis center(s) by confirming all protocol guidelines are met (providing signed consent, HIPAA and safety labs), as well as scheduling visits to establish sufficient venous access prior to scheduling procedure, arranging transport for the subject participants and couriers for specimen delivery to collaborating laboratories for analysis and storage.
• Facilitate histology processing of tissue samples from invasive biopsy procedures.
• Work with UCSF accounting to ensure correct accounts are used for study-related charges and salary support.
• Review invoices and billing statements, provide accounting with study and funding information.
• Setup new laboratory accounts as needed.

Qualifications

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with participants, team members, other departments, and outside institutions and clinicians; and the ability to multi-task in a fast-paced environment while working with a diverse participant population.
• Able to work well independently after training, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Superior organizational skills, oral/written communication skills, attention to detail and accuracy.
• Responsible, motivated, efficient.
• Able to take initiative, prioritize, think critically, and meet deadlines.
• Comfortable working both independently and in a team setting.
• Interpersonal skills necessary to interact effectively with a wide range of health professionals, administrators, and research subjects.
• Comfortable interviewing participants on sensitive issues including high risk sexual practices, sexually transmitted diseases, and substance use.
• Able to carry boxes and supplies weighing up to 20-30 pounds, pack specimens into shipping containers, and deliver specimens to lab in a timely manner.
• Able to file heavy charts (up to 5 lbs.) in file cabinets.
• Proficient in Microsoft Office programs with emphasis on Excel, Access, Word, Publisher.
• Savvy internet user and experience using smartphone applications.
• Demonstrate excellent attendance and reliability.
• Work during some evening hours and/or early morning hours required, possible weekend hours.