Clinical Research Coordinator Infectious Disease

While HIV incidence has declined substantially from four decades ago, our progress will need to accelerate to accomplish the national Ending the HIV Epidemic objectives. PrEP is one of the most powerful tools for HIV elimination, albeit uptake, adherence, and persistence have been uneven across populations. For example, at San Francisco City Clinic (SFCC), San Francisco's municipal sexual health clinic, PrEP use is lower among black/African American patients than those of other race/ethnicities, and much lower among eligible women and people who use drugs (PWUD) compared with men who have sex with men (MSM). SF Department of Public Health (SFDPH) recently funded 7 health access points (HAPs) to deliver low barrier HIV and STI prevention services to priority populations in SF County. The HAP at the Ward 86 HIV Clinic (known as "The Lobby") provides prevention and treatment services to people experiencing homelessness (PEH), PWUD and other people who need low-barrier care access. Lenacapavir, delivered by a biannual injection, may lead to higher rates of persistence given challenges coordinating follow-up ever 8 weeks among a population with intermittent phone access, competing subsistence needs, and a high burden of substance use and mental health challenges. We have previously shown that more rapid PrEP initiation is associated with greater PrEP persistence. This proposal will build on our expertise in both rapid ART and PrEP start, and have a long history of leadership in PrEP implementation. SFCC was one of the 3 participating clinics in the United States PrEP demonstration study, a landmark study that demonstrated the acceptability and feasibility of implementing oral TDF/FTC for PrEP in sexual health clinics and community health centers, and has developed expertise in rapid PrEP implementation. Ward 86's the Lobby has growing experience initiating individuals rapidly on cabotegravir, and has been one of the largest implementers of long‑acting PrEP in the city. SF Getting to Zero's New Product Initiative (NPI) is conducting sentinel surveillance of implementation of biomedical HIV/STI prevention tools in San Francisco, including LA‑PrEP, which will provide key study infrastructure for this proposal. In this study, we propose to assess factors associated with uptake and persistence of LEN for PrEP in real‑world urban settings, along with factors affecting implementation, and develop a toolkit to facilitate LEN implementation in similar clinical settings in other high incidence jurisdictions. In addition to coordinating the LEN PrEP Study at Ward 86, the CRC will be asked to assist with IRB management of Dr. Gandhi's studies, as well as occasionally support sample collection and coordination in Dr. Gandhi's Hair Analytical Lab. 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. Study Coordination and Data Collection (60%) 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 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 consistent quality of 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. Data Management and Reporting of Results (10%) 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. Staff Training (5%) 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 workflow 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. Quality Control Procedures (5%) 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. Study Implementation (5%) 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: scheduling meetings, taking meeting minutes, filing, purchasing. Set up 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. Specimen Management / Maintenance (5%) 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. Protocol Submissions and Adherence (5%) 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. Regulatory Responsibilities (5%) 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. Required Qualifications High School 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 MSWord, Excel, PowerPoint and Outlook. Preferred Qualifications 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. 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 service or research capacity. Experience working with transgender men and women in a service or research capacity. Experience working with culturally diverse groups. Spanish language proficiency. Comfortable speaking with subjects on sensitive issues including sexual practices. Demonstrate excellent attendance and reliability. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Qualtrics and Redcap programming platforms, Stata and/or R experience is a plus. Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines Health Information and Accountability Act (HIPAA) The Protection of Human Research Subjects CHR regulations for recruitment and consent of research subjects Effective Cash Handling Procedures Environmental Health and Safety Training Fire Safety Training Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system. Associate degree or BA/BS. Salary Information The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. To learn more about the benefits of working at UCSF, including total compensation, please visit: Equal Employment Opportunity The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. #J-18808-Ljbffr University of California - San Francisco