Clinical Research Coordinator - Division of HIV
UC San Francisco (UCSF) · San Francisco, California, United States
JOB SUMMARY
The Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital (ZSFG) is an internationally recognized global leader in HIV clinical care, research and education and has grown to encompass a network of specialty clinics, multiple research and clinical trials, an HIV education program, an international research program in East Africa and a vibrant community forum for clinicians and researchers. Housed within the division is the SCOPE (Study on Consequences of Protease Inhibitors Era) and LIINC (Long-term Impact of Infection with the Novel Coronavirus) Research Programs that focuses on clinical and translational research.
The Clinical Research Coordinator (CRC) will work at an independent level to assist the Principal Investigators, project directors, and Senior Clinical Research Coordinators with implementing study protocols, study coordination, data/specimen collection, data management, and quality assurance. The incumbent will recruit, screen, enroll, and follow study participants, and interact with health care providers, clinical researchers, collaborators, funders, and varied administrative and professional staff for a new project known as the PASC-RECOVER (Post-Acute Sequelae of SARS-CoV-2 Infection - Researching COVID to Enhance Recovery) Project.
ABOUT DIVISION OF HIV, INFECTIOUS DISEASES AND GLOBAL MEDICINE
The Division of HIV, Infectious Diseases and Global Medicine at the University of California San Francisco (UCSF) is an internationally recognized global leader in clinical care, research, and education. With its home-base located at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), the Division has been ranked as the top facility in the country for AIDS care since 1983. The Division’s work is featured frequently in the media, and it is often visited by numerous international, national, state, and local dignitaries and delegations. The Division consists of approximately 38 faculty members, 11 fellows/postdoctoral scholars and 170 academic and staff employees. It is the largest Division of the Department of Medicine (DOM) at ZSFG, with a total expenditure budget of approximately $52 million dollars.
%
of time
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
50%
Yes
Study Coordination, and Data Collection
- Identify, interview, and obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure for SCOPE, LIINC, and PASC-RECOVER cohorts including various sub-studies. Take medical histories and assure appropriate inclusion/exclusion criteria by verifying information through outside sources, review of medical reports, and review with the Principal Investigator. Administer questionnaires, train subjects on proper data and specimen collection techniques. Consent subjects for HIV antibody testing. Establish rapport with subjects, respond to their diverse needs, and become their intermediary between physicians and other departments.
- Communicate with Supervisor and Clinical Research Manager regarding study progress and when participant problems or questions require a physician’s involvement. Develop and maintain complex schedules for subjects enrolled in multiple studies. Develop, prepare, and maintain study documents, subject files, and Access databases. Prepare complex laboratory setups and paperwork for specimen collection and tracking. Analyze and triage specimen collection and distribution based on goals of various protocols. Collect, aliquot, or freeze saliva, urine, stool, or other specimens as required. Distribute specimens and paperwork to proper 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, maintain clinical supplies. Ensure all procedures, laboratory tests, and required data are collected at each visit; coordinate follow-up; and complete documentation.
- Provide back-up coverage for other CRCs, under Supervision, in implementing HIV-related clinical research protocols nested within the SCOPE, LIINC, PASC-RECOVER Projects. Coordinate with teams to ensure correct specimens are collected according to protocol at the time of leukapheresis, lymph node biopsy, sigmoidoscopy, upper endoscopy, or colonoscopy.
- Coordinate with the leukapheresis center(s) by confirming all protocol guidelines are met (providing signed consent, HIPAA, and safety labs) scheduling visits for vein checks and apheresis procedures as well, arranging transport for the subject and couriers for specimen delivery to collaborating laboratories for analysis and storage.
- Coordinate with GALT and lymph node teams and processing laboratories to schedule gut biopsy procedures. Instruct subjects on pre/post-op procedures. Ensure specimens are correctly distributed to laboratories for analysis and storage. Assist in room turnover between procedures. Provide accurate documents for billing/tracking procedures and generating research stipend in a timely manner.
- 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.
20%
Yes
Specimen Management/Maintenance
- Assist in the organization and maintenance of specimen processing/collection lab
- Identify and request needed laboratory supplies and place orders in the procurement system
- Maintain inventory of non-expired testing kits and other phlebotomy supplies including vacutainer tubes, winged collection safety needles and other supplies as required.
- Process all specimens as required per protocol/laboratory manual, arrange the exchange of and transport of specimens to other university programs as necessary or for shipping (including packaging and shipping per International Air Transport Association (IATA) requirements as appropriate).
- Ensure integrity and security of samples.
15%
Yes
Data Management and Reporting of Results
- Maintain complex Excel and Access databases. Enter data into Keeptrack, RedCap, or other secure data collection websites. Address database queries, perform basic statistical analysis. Assist in designing case report forms, flow sheets, and data collection forms.
5%
Yes
Staff Training and Accounting
- Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
- Attend and actively participate in regular team meetings.
- Ensure appropriate and accurate charges are applied to the correct study fund. Work directly with accounting department to set up new systems for funding needs as they arise, including developing purchase orders for necessary goods/services. Responsible for constantly managing complex network of funds used for multiple studies.
- Setup and maintain petty cash fund of up to $2000 as well as check requests for research subject stipends. Follow proper subject reimbursement procedures
5%
Yes
Compliance and Regulatory Responsibilities
- Comply with Good Clinical Practice, CHR, HIPAA, Red Cross guidelines and various other regulatory guidelines including working knowledge of BSL2 facilities and specimen collection, and preparation required for immunology laboratory assays.
- Assist in the completion of required documents for the UCSF IRB/Committee on Human Research.
- Resolve conflicts between sites, study sponsors, and collaborators.
- Communicate with high-level personnel at collaborative and regulatory agencies regarding research.
- Respond to general questions regarding subject management and data reporting.
5%
Yes
Program Reporting