Clinical Research Coordinator - Division of HIV

UCSF Health is hiring a Clinical Research Coordinator to manage and execute clinical and translational research studies focused on HIV and related research. The role coordinates study visits, participant recruitment and data collection, specimen processing and shipping, regulatory compliance, and laboratory operations across San Francisco and collaborating research sites.

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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

Preferred

• 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
• Phlebotomy Certification
• Specimen Processing
• PBMC Processing
• PBMC Isolation
• PBMC Cryopreservation
• Blood-Borne Pathogen Handling
• Vulnerable Patient Care
• UCSF/ZSFG Electronic Medical Records
• Clinical Database Development
• Clinical Database Maintenance
• REDCap
• Clinical Software Proficiency
• Clinical Practice
• HIPAA Compliance
• Human Research Subject Protection
• Research Subject Recruitment
• Informed Consent
• Cash Handling Procedures
• Environmental Health
• Microbiological
• Biomedical Biosafety
• Fire Safety

Company

• Integrated hospital and health care network
• San Francisco, California, USA
• https://www.ucsfhealth.org/
• Founded in 1990
• 5001-10000 employees

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
• 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

Required skills

• Blood-Borne Pathogen Specimen Handling, Clinical Practice, Clinical Research, Electronic Medical Records, HIPAA, Human Research Subject Protection, Human Subjects Research, Medical Terminology, Microsoft Excel, Microsoft Outlook, Microsoft Word, PBMC Processing, Phlebotomy, REDCap, Transportation of Dangerous Goods Certification

Preferred skills

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Experience

• Mid level