Clinical Research Coordinator Phlebotomist

JOB DESCRIPTION This position sits within the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital (ZSFG), and supports the LIINC (Long-term Impact of Infection with the Novel Coronavirus) and SCOPE (Study on the Consequences of the Protease Inhibitor Era) Research Programs, which conduct clinical and translational research on acute and post-acute infection syndromes related to COVID-19 and HIV. Job Summary This position sits within the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital (ZSFG), and supports the LIINC (Long-term Impact of Infection with the Novel Coronavirus) and SCOPE (Study on the Consequences of the Protease Inhibitor Era) Research Programs, which conduct clinical and translational research on acute and post-acute infection syndromes related to COVID-19 and HIV. The Clinical Research Coordinator (CRC) is a certified phlebotomist who will conduct in-person research visits at participants’ homes and in clinical settings, drawing blood and collecting other biospecimens, recruiting and consenting participants, and coordinating study activities across multiple protocols. The CRC’s primary assignments will be home- and clinic-based observational and interventional studies of individuals with acute and post-acute infections, with a current focus on COVID-19 and Long COVID. Active protocols include PREVENT-LC (Early Antiviral Treatment to Prevent Viral Persistence and Inflammation as Drivers of Long COVID), PASC-RECOVER (Post-Acute Sequelae of SARS-CoV-2 Infection – Researching COVID to Enhance Recovery), and the LIINC cohort, and the CRC may be assigned to additional home- or clinic-based studies as the Division’s research portfolio evolves. Working independently under the Principal Investigators, Project Directors, and Senior Clinical Research Coordinators, the CRC will implement study protocols, manage data, ensure quality assurance, and coordinate with health care providers, clinical researchers, collaborators, funders, and administrative staff. Several active protocols enroll participants during acute SARS-CoV-2 infection, so the CRC will conduct in-home and in-clinic visits with individuals who are actively infectious with COVID-19 (and, where applicable, other communicable respiratory pathogens), and is required to follow study infection-control protocols and wear UCSF-provided personal protective equipment (PPE) at every visit. The position requires a valid California driver’s license and the use of a vehicle for travel to participant homes throughout the study region. 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. Responsibilities 50% Yes Identify, recruit, consent, and interview subjects for home- and facility-based research protocols, including currently active studies such as PREVENT-LC, PASC-RECOVER, and the LIINC cohort, and their sub-studies. Conduct in-person study visits at participants’ homes and in clinic, driving to home locations throughout the study region as required. Execute the clinical trial protocol as instructed. Follow UCSF infection-control protocols and wear required personal protective equipment (PPE), which will be provided, when conducting visits with participants who are actively infectious with SARS-CoV-2 or other communicable pathogens. Package and deliver specimens to laboratories for processing, and carefully catalog collected specimens. Perform phlebotomy (blood draws) at each visit per protocol, and collect, aliquot, or freeze saliva, urine, stool, and other specimens as required. Educate participants on proper self-collection of biospecimens (e.g., nasal swabs, saliva, stool) and distribute study medications per protocol. Package and ship diagnostic specimens, including liquid-nitrogen shipments and coordinated multi-carrier domestic and international shipments. Prepare laboratory setups and paperwork for specimen collection and tracking, and analyze and triage specimen collection and distribution based on protocol goals. Maintain clinical supplies for study visits. Develop and maintain complex schedules for subjects enrolled in multiple studies, and develop, prepare, and maintain study documents, subject files, and Access databases. Utilize electronic medical records (e.g., Apex, Epic) to review patient files and charts. Communicate with the Supervisor, Clinical Research Manager, and other clinical staff regarding study progress, and elevate participant problems or questions requiring a physician’s involvement. Ensure all procedures, laboratory tests, and required data are collected at each visit; coordinate follow-up; and complete documentation. Demonstrate responsible handling of participant compensation, including cash and/or gift cards, with accurate tracking, secure management, and adherence to UCSF cash policies. Set up and maintain the petty cash fund and check requests for research subject stipends, following proper subject reimbursement procedures. Provide back-up coverage for other CRCs, under supervision, in implementing related clinical research protocols nested within the LIINC and PASC-RECOVER projects. Coordinate with teams to ensure correct specimens are collected according to protocol at the time of upper endoscopy or colonoscopy. Coordinate with the PET/CT scan team by confirming all protocol guidelines are met (providing signed consent, HIPAA, and safety labs). Coordinate with the gut-associated lymphoid tissue (GALT) team 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 stipends 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. Set up new laboratory accounts as needed. 20% Yes Assist in the organization and maintenance of the specimen processing/collection laboratory. 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 Maintain complex Excel and Access databases. Enter data into 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 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. Set up and maintain petty cash fund as well as check requests for research subject stipends. Follow proper subject reimbursement procedures. 5% Yes Comply with Good Clinical Practice, CHR, HIPAA, Red Cross, and other applicable regulatory guidelines, including those governing BSL2 facilities, specimen collection, and the 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 Work with the Principal Investigator in preparing data for scientific abstract, poster, manuscript, and grant submissions and completion of progress reports and required documents. Other duties as assigned. 10 0% To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%. Qualifications Required Qualifications: HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities. Ability to travel to participant homes and community locations throughout the study region. Ability to operate a vehicle for work‑related travel throughout California. Strong organizational and time management skills to coordinate schedules, study materials, and visit documentation. 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 in a home and clinic setting. Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines. Certified phlebotomy experience or equivalent certification to perform phlebotomy. Knowledgeable in phlebotomy issues, including performing phlebotomy, working knowledge of tubes and procedures required for blood draw of clinical laboratory tests, and sample processing for research assays; basic laboratory techniques (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage, and disposal of reagents) Preferred Qualifications 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. Good driving record and familiarity with the City’s geography Experience with electronic medical records. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA 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.). Familiarity with medical terminology, research policies and guidelines, guidelines for handling diagnostic specimens including packing/shipping infectious substances Certified Safe Shipper - IATA certification Experience using Box and REDCap data entry platform Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines Health Insurance Portability 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 with translational research trials, statistics and/or data management; knowledge of clinical research practices and longitudinal cohort studies Experience working with culturally and linguistically diverse groups Minimum of two years’ experience in clinical, community health setting and/or research setting Comfortable interviewing subjects on sensitive issues including high risk sexual practices and illegal drug use Knowledgeable in phlebotomy issues, including working knowledge of tubes and procedures required for blood draw of clinical laboratory tests, and sample processing for research assays; basic laboratory techniques (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage, and disposal of reagents) Conversational Spanish language skills with medical terminology Demonstrate excellent attendance and reliability. Advertising/publishing experience a plus. Proficient in Microsoft Office programs with emphasis on Excel, Access, Word, Savvy internet user Able to carry boxes and supplies (inclusive of a small fridge approximately 40 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 Required Licenses And/or Certifications Licenses and certifications that a candidate must possess to be considered for the position. California Certified Phlebotomy Technician 1 (CPT-1) or equivalent license to perform phlebotomy in the State of California Legal Driver’s License #J-18808-Ljbffr University of California, San Francisco