Clinical Research Coordinator - Division of HIV

Job Description Job Summary: The general purpose of the position is to help manage and execute all clinical and translational research studies for the Principal Investigators. Currently, the supervising Principal Investigator has two multicenter studies, where UCSF is both the coordinating center and a clinical site, the other PIs have several inter-related projects that operate within the supervising PI’s UCSF cohort or with UCSF as a clinical site. In addition, the supervising Principal Investigator has two ongoing studies based in Kampala, Uganda where members of his San Francisco research team help coordinate aspects of this study. More specifically, the main responsibility of the person in this role is to screen, enroll, and conduct study visits with patients; and to collect, process, store, and ship respiratory (i.e., bronchoscopy with bronchoalveolar lavage, BAL), blood, and other bodiy fluid specimens from HIV-infected and HIV-uninfected subjects in San Francisco that will be used for a wide-range of molecular- and cell-based laboratory assays, including 16S rRNA microarrays and Illumina DNA and RNA sequencing, telomere length and telomerase activity assays, polymerase chain reaction (PCR) and enzyme-linked immunosorbent assay ( ELISA ) assays, and unbiased next generation sequencing (NGS) assays . The person will collect and prepare – using sterile laboratory techniques - bronchoscopy with BAL fluid, bronchoscopically-brushed endobronchial cells, and blood (whole blood, serum, plasma, and peripheral blood mononuclear cells (PBMCs), and bodily fluids (semen abd saliva) for molecular- and cell-based laboratory assays; inventory and store these specimens; arrange proper specimen transport (e.g., on dry ice) to collaborating investigators and staff; oversee the incoming data interpretation from samples and ensure that it is utilized correctly for analysis and publications; organize, manage and update specimen transfer inventories; and ensure the integrity and security of samples. Additionally, be responsible for pulmonary function testing including spirometry, for which they will receive the appropriate laboratory training. This involves a minimum of three flow-volume loops per subject, both before and after bronchodilator administration (puffs of albuterol). If any concerns or abnormal results are discovered, the person will be responsible for notifying the subject and their primary care physician. This person will also oversee and receive the shipments of biological specimens from the supervising Principal Investigator’s research site in Kampala, Uganda. This person will purchase all study-related supplies for San Francisco and Uganda and will oversee and assist in the cleaning, organizing, and restocking of an office and a Biosafety Level II (BSL2) laboratory. As such, an educational degree in science, theoretical and technical understanding of the laboratory assays, and prior laboratory experience handling infectious (e.g., HIV+ and TB+) specimens are strongly recommended for this position. The person in this position will work with representatives from the National Institutes of Health, as well as principal investigators, laboratory collaborators, and study personnel from collaborating sites. This person will act as an intermediary between ZSFG and UCSF clinical and research staff to manage all aspects of the Principal Investigators' research studies, which include, but are not limited to all ZSFG, UCSF IRB, and BUA study applications and the day-to-day conduct of study protocols. This person will oversee and assist in the development, execution and, if required, modification and revision of study protocols and laboratory procedures. As such, an in-depth understanding of the laboratory assays being performed and the knowledge and ability to implement the proper biosafety measures are required. The incumbent will work at an independent level to assist the Principal Investigator with implementing study protocols, study coordination, data/specimen collection, data management, and quality assurance. Specimen collection will include oversight of processing and shipping of study samples and, in cases where this person is a certified phlebotomist, performing blood draws. This person will also assist the Principal Investigators in the selection and hiring of new laboratory members. The person in this position will be responsible for training all new laboratory members, which include fellows, residents, study coordinators, laboratory assistants, and volunteers or students in all aspects of clinical and translational research. The person in this position may also be required to execute any and all tasks related to the Principal Investigators’ various studies, which include, but are not limited to the screening, recruiting, and enrolling of subjects and the collecting of clinical data and data entry. The person in this position will be responsible, in collaboration with the supervising Principal Investigator's statistician, for creating new systems for organizing clinical data and clinical specimens. The person in this position will assist in the auditing of all of research-related expenditures. This person will participate in all conference calls and meetings and lead lab meetings with the various investigators. The person in this position will assist the Principal Investigators in preparing grant applications. The person in this position will also be responsible for managing and assisting in the initiation, implementation, and execution all of the Principal Investigators' future research studies. Lastly, the person in this position will help to assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; 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. 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, 14 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 Qualifications Required Qualifications: High School Diploma; or equivalent experienceCurrent certification in Transportation of Dangerous Goods or ability to obtain certification within six months of hireUpon hire, the candidate will obtain (and maintain) required training in Laboratory Safety for Researchers, Biosafety Training, Blood-borne Pathogens Training, Carcinogen Training, Formaldehyde Training, Hazardous Waste Management Training, and Safe Shipper TrainingExperience working with individuals in a clinical or a clinical research setting (for example, explaining medical tests and procedures to patients, explaining research procedures and risk/benefit to potential research subjects) and knowledge with medical terminology, medical testing, and human subjects researchAttention 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 populationAbility to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines and obtain reproducible results. Excellent analytical and problem-solving skillsKnowledge of Microsoft Word, Excel, Outlook, and other basic software programs Preferred Qualifications Certified phlebotomy experience or equivalent certification to perform phlebotomy in the State of CaliforniaExperience with processing specimens such as PBMCs or experience with processing specimens using detailed and advanced protocols (i.e.: familiarity with PBMCs or using specimen processing protocols to isolate and cryopreserve PBMCS); experience with blood-borne pathogen specimen handlingExperience working with vulnerable populations of patients in a medical settingExperience with UCSF/ZSFG electronic medical recordsExperience with developing and maintaining clinical databases using RedCAP and other types of softwareExperience applying the following regulations and guidelines:Good Clinical Practice GuidelinesHealth Information and Accountability Act (HIPAA)The Protection of Human Research SubjectsRegulations for recruitment and consent of research subjectsEffective Cash Handling ProceduresEnvironmental Health and Safety Training CDC’s Biosafety in Microbiological and Biomedical LaboratoriesFire Safety Training License/Certifications Upon hire, the candidate will obtain (and maintain) required training in Laboratory Safety for Researchers, Biosafety Training, Blood-borne Pathogens Training, Carcinogen Training, Formaldehyde Training, Hazardous Waste Management Training, and Safe Shipper TrainingCurrent certification in Transportation of Dangerous Goods or ability to obtain certification within six months of hire