Clinical Research Supervisor

Job SUmmary: 

The Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital (ZSFG) is an internationally recognized global leader in HIV clinical care, research and education and has grown to encompass a network of specialty clinics, multiple research and clinical trials, an infectious diseases/HIV education program, an international research program in East Africa and a vibrant community forum for clinicians and researchers. Dr. Lee’s research group, housed within the division, focuses on clinical and translational research, and in particular, clinical trials and observational cohort studies that focus on HIV and infectious diseases, such as SARS-CoV-2 infection. 

The purpose of the position is to function as a Clinical Research Supervisor for the clinical research activities of protocols under the Division of HIV, Infectious Diseases and Global Medicine investigating Long COVID as well as HIV. The Clinical Research Supervisor will work independently primarily across all research studies including interventional and observational studies in the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital, and to train and supervise its staff, coordinate, and account for its overall administration. The Clinical Research Supervisor’s oversight will apply to the entire Clinical Research team in the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital. The Clinical Research Supervisor, in addition to a study statistician and a study physician providing medical coverage will directly manage the operations of 4-6 active studies at a time, including direct study participant interaction on-site, for multiple Principal Investigators, and several legacy studies in the data analysis phase. The Clinical Research Supervisor will train and supervise approximately 2-3 coordinators working across projects, while upholding overall coordination, administrative, financial, and regulatory responsibilities, including reporting progress to IRBs, study sponsors, and other stakeholders.

The Clinical Research Supervisor will ensure that the needs of projects are met through the efforts of supervised Clinical Research Coordinators, statisticians, bioinformaticians, and study physicians. The Clinical Research Supervisor will ensure compliance with clinical study protocols that involve human subjects, will oversee and resolve operational aspects of studies in conjunction with the project team and in accordance with standard operating procedures and good clinical practice and regulations. The Clinical Research Supervisor will assess the progress of the team as a whole, will set directives, and hold regular staff meetings to train and verify quality assurance. Additionally, the Clinical Research Supervisor will manage relationships with units where research is being performed (examples: CTSI research units and core laboratories) by communicating with Directors of those units the research goals and staff operations; will coordinate the efforts of staff working on those units; will train and provide feedback as necessary. 

The Clinical Research Supervisor will maintain all study related forms and procedures and will update as operations change. The Clinical Research Supervisor will also be responsible for working with the finance team to manage budgets, review monthly invoices, and maintain oversight of participant reimbursement. 

The Clinical Research Supervisor will perform efficient integration of regulatory requirements, ethical compliance, data management, and participant coordination. The Clinical Research Supervisor will demonstrate substantial leadership skills in supervising CRCs and in partnering with various UCSF organizations (e.g. UCSF Institutional Review Board, Pre & Post Award Financial Analysts, Human Resources, etc.), and with outside study Sponsors and study monitors. Reporting to the Principal and Co-Principal Investigators in the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital, the Clinical Research Supervisor will support the clinical study management of multiple concurrent studies, typically requiring advanced-level knowledge and skills. They may provide leadership to junior clinical research coordinators and/or other support personnel.

The position has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical studies (both NIH and industry-sponsored), local investigator-initiated clinical studies, and/or programmatic clinical research activities, such as a clinical database and biorepository.  Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, e