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, 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.

Department Overview (please write a brief description of your department/unit that you would like to be included in the job posting/advertisement)

ABOUT DIVISION OF HIV, INFECTIOUS DISEASES AND GLOBAL MEDICINE:

The Division of HIV, Infectious Diseases and Global Medicine at the University of California San Francisco (UCSF) is an internationally recognized global leader in clinical care, research, and education. With its home-base located at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), the Division has been ranked as the top facility in the country for AIDS care since 1983. The Division's work is featured frequently in the media, and it is often visited by numerous international, national, state, and local dignitaries and delegations. The Division consists of approximately 36 faculty members, 11 fellows/postdoctoral scholars and 170 academic and staff employees. It is the largest Division of the Department of Medicine (DOM) at ZSFG, with a total expenditure budget of approximately $52 million dollars.

%

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 supplies needed for assigned protocols. Coordinates with administrative staff.
• Development and implementation sample maintenance of biological specimens (appropriate for each designated study protocol) as well as coordination of shipment of biospecimens to collaborators.
• Identify and request needed laboratory supplies and place orders in the procurement system
• Maintain inventory of non-expired testing kits and other phlebotomy supplies including vacutainer tubes, winged collection safety needles and other supplies as required.
• Process all specimens as required per protocol/laboratory manual, arrange the exchange of and transport of specimens to other university programs as necessary or for shipping (including packaging and shipping per International Air Transport Association (IATA) requirements as appropriate).
• Ensure integrity and security of samples.
• Training development and implementation of hospital-based research personnel (lab techs, nursing staff, etc.) and supervision of a Study Physician
• Management of recruitment process for all study protocols.
• Oversees/participates in data entry of clinical data from patient's hospital/research charts.
• Plans and coordinates participant reimbursement.
• Drafts progress reports to be sent to Study Sponsors.
• Drafts Safety Monitoring Committee or Data Safety Monitoring Board summaries for trials.

10

Yes

Risk Management:

• Comply with Good Clinical Practice, CHR, HIPAA, Red Cross guidelines and various other regulatory guidelines including working knowledge of BSL2 facilities and specimen collection and preparation required for immunology laboratory assays.
• Trains in federal and local research laws and guidelines.
• Protects the University from non-compliance and potential litigation by ensuring contract compliance, meeting local and federal laws, and ensuring compliance with hiring and supervision laws; implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success.
• Acts as regulatory authority and advisor by training and educating employees and advising leadership and PI's.
• Manages audits. Oversees and assists study coordinators in preparing for audits. Assists staff assigned with monitoring site compliance.
• Ensures data is sufficient and updated, including all regulatory documentation.
• Helps institute and maintain a Quality Improvement Process.

5

Yes

Financial Management:

• Ensure appropriate and accurate charges are applied to the correct study fund. Work directly with accounting department to set up new systems for funding needs as they arise, including developing purchase orders for necessary goods/services. Responsible for constantly managing complex network of funds used for multiple studies.
• Oversees budgets, invoices, purchasing and reimbursements including petty cash funds and other forms of reimbursement.
• Along with the finance and procurement teams, setup vendor contracts.
• Ensures billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients. Guide subjects through financial process (private vs. federal studies and their relationship to insurance reimbursement) to ensure accurate payments are made and subject not held responsible
• Reviews budget reports on a monthly basis.

• Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds.

• Ensures that the use of research funding is in compliance with funding agency protocols.

• Assist PI in grant budget development.

100%

(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

Required Qualifications:

• Bachelor's degree in basic biological sciences (e.g., Biology, Human Biology, Neuroscience)

• Minimum of 2 to 4 years working in research at UCSF or similar academic institution

• Working knowledge of clinical or laboratory research, clinical trial and cohort recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting

• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research

• Critical thinking skills to evaluate issues and identify a potential solution

• Clear and concise communicator; good verbal and written communication skills; both

• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration

• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical management systems

• Ability to perform basic statistical analyses using commonly used clinical statistical software such as STATA, SAS, or R

• Ability to perform a scientific literature search, summarize multiple scientific papers, and prepare an in-person presentation to a diverse audience of clinical, basic science, and computational investigators.

• Ability to travel to and work in person at multiple UCSF sites

• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals

• Demonstrated experience in training others, particularly in the field of research

• Demonstrated experience translating grant proposals to working protocols to be utilized by study team members

• Project management skills to oversee the administrative operations of clinical studies; knowledge of strategies for recruiting human subjects

• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills

• Ability to analyze complex and non-routine issues requiring innovative solutions

• Ability to operate effectively in a changing organizational and technological environment

• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines

• Ability to interpret and apply policies and regulations

• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets

• Significant project and clinical study management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities

• Experience using database software

• Experience with grant application procedures, personnel documentation, contract generation

• and subcontracting, preferably at UCSF

• Experience with translational research studies, statistics and/or data management; knowledge of clinical research practices and longitudinal cohort studies

• Basic knowledge of statistical analysis

Preferred Qualifications:

• Master's in public health, Epidemiology, or Biostatistics

• Clinical Trial Professional certification from a professional society within one year in position

• Knowledgeable in sample processing for T-cell assays, flow cytometry, and other research assays; basic laboratory techniques (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage, and disposal of reagents)

• Experience working in a research laboratory

• Experience with electronic medical records

Required Qualifications:

• Bachelor's degree in basic biological sciences (e.g., Biology, Human Biology, Neuroscience)

• Minimum of 2 to 4 years working in research at UCSF or similar academic institution

• Working knowledge of clinical or laboratory research, clinical trial and cohort recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting

• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research

• Critical thinking skills to evaluate issues and identify a potential solution

• Clear and concise communicator; good verbal and written communication skills; both

• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration

• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical management systems

• Ability to perform basic statistical analyses using commonly used clinical statistical software such as STATA, SAS, or R

• Ability to perform a scientific literature search, summarize multiple scientific papers, and prepare an in-person presentation to a diverse audience of clinical, basic science, and computational investigators.

• Ability to travel to and work in person at multiple UCSF sites

• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals

• Demonstrated experience in training others, particularly in the field of research

• Demonstrated experience translating grant proposals to working protocols to be utilized by study team members

• Project management skills to oversee the administrative operations of clinical studies; knowledge of strategies for recruiting human subjects

• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills

• Ability to analyze complex and non-routine issues requiring innovative solutions

• Ability to operate effectively in a changing organizational and technological environment

• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines

• Ability to interpret and apply policies and regulations

• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets

• Significant project and clinical study management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities

• Experience using database software

• Experience with grant application procedures, personnel documentation, contract generation

• and subcontracting, preferably at UCSF

• Experience with translational research studies, statistics and/or data management; knowledge of clinical research practices and longitudinal cohort studies

• Basic knowledge of statistical analysis

Preferred Qualifications:

• Master's in public health, Epidemiology, or Biostatistics

• Clinical Trial Professional certification from a professional society within one year in position

• Knowledgeable in sample processing for T-cell assays, flow cytometry, and other research assays; basic laboratory techniques (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage, and disposal of reagents)

• Experience working in a research laboratory

• Experience with electronic medical records