Clinical Research Supervisor

UCSF•San Francisco, CA

10d•Onsite

About The Position

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. The research group focuses on clinical and translational research, including clinical trials and observational cohort studies for HIV and infectious diseases like SARS-CoV-2. This position functions as a Clinical Research Supervisor for clinical research activities related to Long COVID and HIV studies. The supervisor will work independently across various research studies, train and supervise staff, coordinate activities, and manage overall administration. This role directly manages the operations of 4-6 active studies at a time, including direct participant interaction, for multiple Principal Investigators. The supervisor will train and oversee approximately 2-3 coordinators, while handling administrative, financial, and regulatory responsibilities, including reporting to IRBs and sponsors. The Clinical Research Supervisor ensures project needs are met, oversees compliance with protocols, resolves operational issues, assesses team progress, sets directives, and conducts staff meetings for quality assurance. They will also manage relationships with research units, coordinate staff efforts, and provide training and feedback. Budget management, invoice review, and participant reimbursement oversight are also key responsibilities. The role requires efficient integration of regulatory requirements, ethical compliance, data management, and participant coordination, demonstrating strong leadership skills in supervising CRCs and partnering with various UCSF organizations and external sponsors. Reporting to Principal and Co-Principal Investigators, the supervisor supports clinical study management of multiple concurrent studies, potentially providing leadership to junior staff. The position has direct responsibility for implementing diverse research activities, including multicenter clinical studies, local investigator-initiated studies, and programmatic research activities. This leadership role ensures clinical research commitments are met and programs maintain a reputation for excellence.

Requirements

Advanced-level knowledge and skills in clinical research management.
Substantial leadership skills.
Ability to effectively work with a variety of people and organizations at UCSF and elsewhere.
In-depth knowledge of specific programs.
Strong administration and management leadership of clinical research.
Strong research coordination skills.
Expert and efficient integration of multiple complex programmatic activities.
Sophisticated medical knowledge base.
Experience in supervising CRCs.
Experience in partnering with various UCSF organizations (e.g. UCSF Institutional Review Board, Pre & Post Award Financial Analysts, Human Resources) and with outside study Sponsors and study monitors.
Experience in 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.
Experience in ensuring IRB approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical studies, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts.
Experience in creating and implementing quality improvement processes.

Nice To Haves

Experience working with a multi-disciplinary team working on efforts to cure and treat HIV and SARS-CoV-2 infection to identify potential novel targets for therapeutic intervention.
Experience adapting novel analysis tools to identify how infections cause disease in the host.

Responsibilities

Function as a Clinical Research Supervisor for clinical research activities of protocols investigating Long COVID and HIV.
Work independently across all research studies including interventional and observational studies.
Train and supervise clinical research staff, including approximately 2-3 coordinators.
Coordinate and account for the overall administration of clinical research activities.
Directly manage the operations of 4-6 active studies at a time, including direct study participant interaction.
Uphold overall coordination, administrative, financial, and regulatory responsibilities.
Report progress to IRBs, study sponsors, and other stakeholders.
Ensure that the needs of projects are met through the efforts of supervised staff.
Ensure compliance with clinical study protocols that involve human subjects.
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.
Assess the progress of the team as a whole, set directives, and hold regular staff meetings to train and verify quality assurance.
Manage relationships with units where research is being performed, communicating research goals and staff operations.
Coordinate the efforts of staff working on those units, and train and provide feedback as necessary.
Maintain all study related forms and procedures and update as operations change.
Work with the finance team to manage budgets, review monthly invoices, and maintain oversight of participant reimbursement.
Perform efficient integration of regulatory requirements, ethical compliance, data management, and participant coordination.
Demonstrate substantial leadership skills in supervising CRCs and in partnering with various UCSF organizations and external study sponsors and monitors.
Support the clinical study management of multiple concurrent studies.
Provide leadership to junior clinical research coordinators and/or other support personnel.
Implement a diverse portfolio of research activities for one or more studies.
Ensure IRB approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical studies, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts.
Exercise strong administration and management leadership of clinical research.
Ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution.
Create and implement quality improvement processes.
Ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.
Manage the various projects in Dr. Lee’s research group.
Provide critical support for clinical translational research.