Clinical Research Coordinator - Division of HIV

UCSF•San Francisco, CA

5d•$40 - $65

About The Position

The Clinical Research Coordinator helps manage and execute clinical and translational research studies for Principal Investigators in the Division of HIV, Infectious Diseases and Global Medicine. The studies include multicenter projects for which UCSF serves as a coordinating center and clinical site, related UCSF cohort projects, and studies based in Kampala, Uganda. The coordinator works with Principal Investigators, NIH representatives, laboratory collaborators, study personnel, and clinical and research staff at ZSFG and UCSF. The role works independently under the general direction of the Principal Investigator to coordinate protocols, data and specimen collection, data management, and quality assurance. The coordinator screens, recruits, consents, and enrolls participants; schedules and conducts study visits; collects clinical data; reviews medical records; administers surveys; and performs pulmonary function testing, including spirometry before and after bronchodilator administration. The coordinator collects, processes, stores, inventories, and ships respiratory, blood, and other biological specimens from HIV-infected and HIV-uninfected participants. Specimens may include bronchoalveolar lavage fluid, bronchoscopically brushed endobronchial cells, whole blood, serum, plasma, PBMCs, semen, and saliva. The work includes maintaining specimen integrity and security, coordinating shipments from Uganda, maintaining shipping and transfer logs, and supporting laboratory assays and subsequent data interpretation and analysis. Phlebotomy may be performed if the coordinator is certified. The position creates and maintains clinical and specimen databases and data-capture instruments, prepares datasets for analysis, maintains protocol and procedure manuals, and helps develop or revise study protocols and laboratory procedures. It assists with IRB/CHR submissions and renewals, grant preparation, regulatory documentation, compliance, quality control, audits, expenditure reconciliation, and progress reporting. The coordinator orders study supplies, maintains specimen freezers and laboratory equipment, helps organize and clean a BSL-2 laboratory, trains new laboratory members, and participates in research meetings. The role may also assist with selecting and hiring laboratory members and initiating and executing future studies.

Requirements

High school diploma or equivalent experience.
Current Transportation of Dangerous Goods certification, or ability to obtain it within six months of hire.
Ability to obtain and maintain required training in Laboratory Safety for Researchers, Biosafety, Blood-borne Pathogens, Carcinogen, Formaldehyde, Hazardous Waste Management, and Safe Shipper procedures.
Experience working with individuals in a clinical or clinical research setting, including explaining tests, procedures, and research risks and benefits to patients or potential research participants.
Knowledge of medical terminology, medical testing, and human-subjects research.
Strong attention to detail, interpersonal skills, and effective verbal and written communication skills.
Ability to coordinate with participants, team members, departments, and outside institutions; multitask in a fast-paced environment; and work with a diverse participant population.
Ability to work independently, complete projects on time, prioritize multiple projects and deadlines, and obtain reproducible results.
Excellent analytical and problem-solving skills, including the ability to resolve specimen collection, processing, and storage issues independently.
Knowledge of Microsoft Word, Excel, Outlook, and other basic software programs.
Ability to comply with and maintain required research, laboratory safety, biosafety, and specimen-shipping training.

Nice To Haves

Certified phlebotomy experience or equivalent certification to perform phlebotomy in California.
Experience processing specimens such as PBMCs, including familiarity with detailed protocols to isolate and cryopreserve PBMCs.
Experience handling blood-borne pathogen specimens.
Experience working with vulnerable patient populations in a medical setting.
Experience with UCSF/ZSFG electronic medical records.
Experience developing and maintaining clinical databases using REDCap and other software.
Experience applying Good Clinical Practice Guidelines, HIPAA, human-subject protections, research recruitment and consent regulations, effective cash-handling procedures, Environmental Health and Safety training, CDC biosafety guidance, and fire safety training.
Science education and theoretical and technical understanding of laboratory assays.
Prior laboratory experience handling infectious specimens, such as HIV-positive and TB-positive specimens.

Responsibilities

Screen, recruit, consent, and enroll research participants for study protocols.
Schedule and conduct participant study visits; collect clinical data, enter data into databases, administer surveys, and review medical records and electronic medical records.
Conduct pulmonary function testing, including spirometry before and after bronchodilator administration, and notify participants and their primary care physicians about concerns or abnormal results.
Collect, process, store, inventory, and ship study specimens, including respiratory, blood, and other bodily-fluid specimens; perform phlebotomy if certified.
Coordinate receipt of biological specimen shipments from the Principal Investigator’s Kampala, Uganda research site.
Maintain specimen integrity and security, freezers, specimen transfer inventories, shipping logs, and specimen protocols and procedures manuals.
Arrange appropriate specimen transport, including shipments on dry ice, to collaborators and staff.
Create and maintain clinical and specimen-related databases and data-capture instruments, including REDCap, Excel, and R; prepare datasets from San Francisco and Uganda for analysis.
Support study coordination and collaborate with study coordinators, investigators, fellows, NIH representatives, laboratory collaborators, and staff at other sites.
Assist with institutional review and preparation, modification, renewal, and submission of UCSF CHR/IRB protocols and related documents; maintain systems for protocol adherence.
Help prepare grants, enrollment and study update reports, regulatory documents, and reports for investigators and granting agencies.
Ensure studies comply with applicable federal regulations, Good Clinical Practice, UCSF requirements, and other relevant regulatory requirements.
Maintain regulatory documents, oversee data integrity, implement periodic quality-control procedures, and participate in internal and external audits or reviews.
Assist the Principal Investigator with reconciling financial expenditures and auditing research-related expenditures.
Order study and laboratory supplies; maintain supply inventories; clean and organize the BSL-2 laboratory; and arrange annual biosafety cabinet certification and freezer inspection and maintenance.
Obtain and maintain required safety and shipping training, including Transportation of Dangerous Goods certification within six months of hire.
Train new laboratory members and staff on research protocols and protocol changes; assist with selection and hiring of laboratory members.
Participate in and lead laboratory meetings, attend conference calls and meetings, and foster a collaborative and professional team environment.
Assist with initiating, implementing, and executing current and future research studies and perform other duties as assigned.