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The Clinical Research Coordinator (CRC) will support study implementation for the SPLASH study, a program at Ward 86 designed to expand access to long-acting antiretroviral therapy (LA-ART) for people living with HIV who face barriers to adherence with daily oral therapy. SPLASH evaluates innovative clinical and implementation strategies to deliver long-acting injectable antiretroviral therapy within a safety-net HIV clinic serving a diverse population including people experiencing homelessness, substance use disorders, and structural barriers to care. It will also examine predictors of failure on long-acting ART, including drug levels and the HIV viral reservoir.
The CRC will focus on participant-facing study activities for the SPLASH study. The CRC will engage in recruitment, informed consent, accurate and timely data collection, entry, and quality assurance within study databases (e.g., REDCap). The CRC will work closely with clinical and research staff to align study procedures with routine clinical care, assist with specimen collection and transport, and ensure proper documentation of study activities. They will also contribute to maintaining regulatory files and ensuring compliance with study protocols and institutional requirements. The CRC, will support identifying, recruiting, screening, and enrolling eligible participants, as well as coordinating baseline and follow-up study visits.
The CRC will work closely with investigators and clinician collaborators to ensure high-quality data collection and participant retention throughout the study. The role requires strong organizational skills, attention to detail, and the ability to work with a diverse population of people living with HIV in a busy clinical environment. The CRC will also participate in study meetings, contribute to quality assurance activities, and may assist with data preparation and analyses under supervision of the study investigators.
The Clinical Research Coordinator's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; transport specimens; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of other Clinical Research Coordinators (CRC) Assistant Clinical Research Coordinators (Ast CRC), and assist PI with oversight of other research staff; manage Investigator's protocols in the Committee on Human Research (CHR) online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; and participate in any internal and external audits or reviews of study protocols. The incumbent will recruit, screen, enroll, and follow study participants, and interact with the study research data analyst, other clinical research coordinators, clinical researchers, collaborators, and funders.
The CRC position requires the incumbent to adhere to research protocols with an emphasis on organizational skills and attention to detail. In addition, given that the employee will be working with people living with HIV and transgender men and women, past experience or strong interest in working with some or all of these populations would be highly beneficial. The CRC will respond to communications from participants through online forums and assist them in completing study procedures, so strong communication skills will be important. The CRC will meet regularly with the principal investigator and research data analyst for the studies to ensure study milestones are met.
Department Description:
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.
Responsibilities
of time
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
60%
YES
Study Coordination and Data Collection

• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
• Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits.
• Prepare laboratory setups and paperwork for specimen collection and tracking.
• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Assist patients as necessary with reading or computer-literacy deficits when using the self-administered web-based study tool to ensure as consistent a quality as possible in the responses.
• Clarify questions that may arise from these self-administered health surveys.
• Provide back-up coverage for other CRCs, under Supervision, in implementing HIV- and PrEP-related clinical research protocols
• Miscellaneous other tasks as needed to support and coordinate the study

10%
YES
Data Management and Reporting of Results

• Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner. The most commonly used database in our group is Redcap.
• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
• Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Work with the PI/PD to maintain complete and accurate data in the study database; analyze the data as they become available.

5%
YES
Staff Training

• Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
• Attend and actively participate in regular team meetings.
• Document work flow and create/update protocols for training and grant-reporting purposes.
• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures

5%
YES
Quality Control Procedures

• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures

5%
YES
Study Implementation

• Modify data collection instruments
• Help schedule staff time and coordinate staff schedules.
• Maintain subject tracking systems.
• Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
• Other administrative duties as necessary e.g., scheduling meetings, taking meeting minutes, filing, purchasing.
• Setup and maintain petty cash fund of up to $2000 as well as check requests for research subject stipends and manage gift card reimbursements. Follow proper subject reimbursement procedures.
• 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.
• Assist in the management of a complex network of vendors used for study related costs for lab/office supplies, subject transportation, courier and clinical lab services etc.

5%
YES
Specimen Management/ Maintenance

• Arrange or perform the exchange of and transport of specimens.
• Identify and request needed laboratory supplies and place orders in the procurement system.
• Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
• Ensure integrity and security of samples.

5%
YES
Protocol Submissions and Adherence

• Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
• Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
• Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance.
• Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
• Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

5%
YES
Regulatory Responsibilities

• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Initiate and follow-up on CHR submissions and modifications; track approval status.
• Interface with departments to obtain UCSF approval prior to study initiation.
• Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.

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%.)
Qualifications
Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Proficiency in MS Word, Excel, PowerPoint and Outlook

Preferred Qualifications:

• BA/BS or Associate's degree
• Experience using Qualtrics and/or Redcap for survey administration
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
• Experience in communicating remotely with study participants (i.e. via email, text, or video chat); 6 months experience in survey research that includes sensitive content, or an equivalent combination of education and experience
• Experience with translational research trials, statistics and/or data management; knowledge of clinical research practices and longitudinal cohort studies
• Experience working with people living with HIV in a