About The Role

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

of time

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)
20% YES

Data Management and Reporting of Results

Create and maintain electronic databases for clinical and specimen-related data in RedCAP
Assist with electronic database management and the design and maintenance of data capture instruments, including REDCap, Excel, and R.
Prepare datasets generated from both San Francisco and Uganda sites for future data analysis.

20% YES

Specimen Collection, Processing, management, and Maintenance

Obtain and maintain training in Laboratory Safety for Researchers Biosafety Training, Blood-borne Pathogens Training, Carcinogen Training, Formaldehyde Training, Hazardous Waste Management Training, and Safe Shipper Training, plus any additional training required by the PI, his collaborators, ZSFG/UCSF, or regulatory bodies
Obtain within first 6-months of hire and maintain certification in Transportation of Dangerous Goods.
Collect, process, store, and ship study-related 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.
Coordinate and receive the shipments of biological specimens from the supervising PI’s research site in Kampala, Uganda.
Inventory and properly store the San Francisco and Uganda specimens.
Ensure the specimen integrity and security of samples.
Maintain and clean all specimen freezers; obtain annual biosafety cabinet certification and freezer inspection and maintenance.
Arrange proper specimen transport (e.g., dry ice) to collaborating investigators and staff.
Create, organize, manage, and update specimen transfer inventories and shipping logs including merging data with existing logs.
Must be able to independently problem-solve issues or problems related to specimen collection, processing, and storage. Create and maintain specimen protocols and procedures manuals.
Create and maintain supplies inventory and order new laboratory supplies.
Clean and organize a Biosafety Level II (BSL 2) laboratory.
Create and maintain specimen protocols and procedures manuals.
Work independently but under the general direction of the PI.
Must be able to independently problem-solve issues or problems related to specimen collection, processing, and storage on own.
Must be able to make decisions in non-standard situations that lead to the development of new or modification of current study protocols.
Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.

Perform phlebotomy/blood draws, if certified in phlebotomy.
40% YES

Study Coordination and Data Collection

Work with current Study Coordinators on collaborative efforts related to the PIs’ studies, including to:
Screen potential research subjects for each study
Recruit potential research subjects for each study
Practice informed consent and enroll subjects for each study
Interface with collaborators from other labs and working groups and support their staff to enroll subjects in related efforts
Schedule research subjects for study visits for each study
Collect data during subject visits; enter data from study visits into databases
Conduct pulmonary function testing
Administer surveys to enrolled participants
Collect and process specimens as above.
Conduct medical charts and electronic medical records reviews for data collection. Work directly with the principal investigators, research fellows, and representatives from federal agencies (i.e.: National Institutes of Health) to create, implement, and maintain NIH funded multicenter, international research studies.

10% YES

Protocol Submissions and Adherence

Assist with institutional review, including preparation, modification, and submission of protocols
Work under the PIs’ direction to assist with grant preparation.
Work with the PIs to prepare required documents for the UCSF Committee on Human Research (CHR).
Renew, modify, and submit CHR protocols.
Generate enrollment and study update reports for granting agencies and Institutional Review Board (IRB) annual renewals/modifications.
Develop and maintain systems for assuring protocol adherence.
Participate in the review and writing of protocols and related procedures to ensure IRB approval within University compliance.

5% YES

Regulatory Responsibilities

Assure studies are carried out according to the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Maintain all regulatory documents.
Work with supervising PI to reconcile financial expenditures.

5% YES

Staff Training

Help train staff and others on new research protocols, changes in protocols.
Attend and actively participate in Weekly Lab meetings with each PI.
Assist the PIs in fostering a collaborative, productive, positive, and encouraging team science environment.
Participate in lab meetings in the Division of Experimental Medicine when a PI or a member of the group is presenting.
Maintain professionalism and collegiality in conducting the above responsibilities
Communicate any work-related issues in a timely and organized fashion and work with the PIs to foster a collaborative, productive, positive, work environment.

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%.)

Required Qualifications

High School Diploma; or equivalent experience
Current certification in Transportation of Dangerous Goods or ability to obtain certification within six months of hire
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 Training
Experience 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 research
Attention 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 population
Ability 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 skills
Knowledge 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 California
Experience 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 handling
Experience working with vulnerable populations of patients in a medical setting
Experience with UCSF/ZSFG electronic medical records
Experience with developing and maintaining clinical databases using RedCAP and other types of software
Experience applying the following regulations and guidelines:
Good Clinical Practice Guidelines
Health Information and Accountability Act (HIPAA)
The Protection of Human Research Subjects
Regulations for recruitment and consent of research subjects
Effective Cash Handling Procedures
Environmental Health and Safety Training
CDC’s Biosafety in Microbiological and Biomedical Laboratories
Fire 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 Training
Current certification in Transportation of Dangerous Goods or ability to obtain certification within six months of hire