Job Description

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, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.

The incumbent may have central responsibility for 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; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes. This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.

The job provides an exciting opportunity to work 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. The position will be to manage the various projects in Dr. Lee's research group. The position will provide critical support for clinical translational ("bench-to-bedside") research, adapting novel analysis tools to identify how infections cause disease in the host.

Responsibilities

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

55
Yes
Research Project & Staff Supervision

Monitors the progress of work of assigned staff. Researches and resolves issues and discrepancies. Manages subordinates' quality and quantity of work to ensure unit meets its objectives. Meets with supervsied staff regularly and reports performance evaluation to management. Distributes work.

• Oversees all research study and research staff operations at multiple centers, including physically working on-site at UCSF research locations at ZSFG. Reports to PIs on study progress, any issues causing delay, and independently handles all staff delegations and work flow.
• Manages relationships with all units where research is performed (research center, CRS, internal & external laboratories) by communicating study objectives and checking on staff performance on those units.
• Provides ongoing staff training, and documents training in all regulatory binders and to the Study Sponsor.
• Distributes work to Clinical Research Coordinators and monitors their progress.
• Maintain complex Excel and Access databases. Enter data into RedCap or other databases. Address database queries, perform basic statistical analysis. Assist in designing case report forms, flow sheets, and data collection forms.
• Supervises Clinical Research Coordinators to ensure compliance. Trains employees on research regulatory processes, database entry, and working with participants. Implements and maintains defined research study processes.
• Serves as a liaison between staff and reports work effort to the PI(s). Cultivates communication and teamwork between cross-functional teams working on research.
• Leads weekly Research Team Meetings. Summarizes key group objectives, provides training on new topics and verifies procedures for quality assurance.
• Works with the statisticians and bioinformaticians and monitors the timeliness and quality of data collection, submission and completion. This includes training new study coordinators in collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events and protocol adherence to federal regulations.
• Oversees monitoring visits and assists study coordinators in preparing for audits. Ensures data is sufficient and updated, including all regulatory documentation. Uses REDCap to generate reports and quality assurance of required data entry. Attends all meetings with auditors. Assists staff assigned with monitoring site compliance. Creates and enforces Corrective Action Plans (CAPs) as needed.
• Recruits and trains clinical research coordinators in collaboration with leadership.
• Mentors clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry.
• Helps manage personnel needs
• Recommends salary actions, promotions, and terminations. Recommends personnel-related actions. Participates in the recruitment and orientation of new employees.
• Evaluates assigned staff performance and reports to management. Provides guidance and excellent judgement. Seen as a role model by assigned staff.

20
Yes
Research Operations Management

• Determines interest of groups in clinical study participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-study agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.
• Provides ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects' options, and ensure that documentation and storage of study files meets legal requirements.
• Ensures optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all IRB documents are up to date.
• Oversees preparation of new IRB applications; arrange paperwork for renewal of existing protocols; respond to IRB requests for revisions; and coordinate protocol changes with study sponsors.
• Ensures reporting of protocol violations to study sponsors and reporting of adverse events to the IRB in a timely manner.
• Responds to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.
• Develops project plans, interview key sponsors, and deliver tangible project results
• Provides periodic status reports to project executives and coordinate documentation and archiving of project deliverables
• Designs and performs ad-hoc performance analysis of the projects and the project staff
• Builds flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic studies and research projects
• Performs business process review, operational reviews and design and implement workflow and controls
• Develops project-related presentation materials for study

10
Yes
Research Implementation:

Initiates a clinical study. Oversees and reviews study and helps create systems and forms to ensure research billing, packets for recruitment and calendars are developed. Reviews accrual and eligibility for each participant enrolled in a clinical study to ensure human subject protection regulations are in compliance and quality recruitment. Multi-tasks and prioritizes to smoothly coordinate studies and ensure patient safety.

• Work with the Principal Investigator in preparing data for scientific abstract, poster, manuscript, and grant submissions and completion of progress reports and required documents. Other duties as assigned.
• Ensures continued compliance, submits amendment updates and protocols to the IRB, maintain study files, ensure audit readiness, recruit patients, and track enrollment; leads staff to ensure proper close-out of studies, discuss subjects' options, and ensures that documentation and storage of study files & investigational product meets legal requirements.
• Protocol set-up: participates in preparing clinical study protocols to be submitted to the UCSF IRB. Advises investigators regarding feasibility of assigned protocols prior to final submission.
• Maintains all study related forms (e.g., case report forms, standard questionnaires) and procedures; will update as operations change
• Researches and plans the acquisition of equipment and su