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, but uptake, adherence, and persistence have been uneven across populations. This role supports the Lenacapavir (LEN) PrEP Study at Ward 86, providing rapid initiation and implementation of long‑acting PrEP in a real‑world urban setting. The Clinical Research Coordinator will assist with IRB management, sample coordination, clinical research study management, regulatory compliance, and data collection for Dr. Gandhi’s projects and the SEN study. The incumbent will recruit, screen, enroll, and follow study participants, and collaborate with data analysts, other CRCs, researchers, collaborators, and funders. Responsibilities 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. Obtain informed consent, review information with subjects, and advocate for patient safety throughout each protocol procedure. Oversee subject reimbursement and resolve discrepancies and issues. Ensure specimens are properly stored and required data are collected at visits. Prepare laboratory setup and paperwork for specimen collection and tracking. Coordinate, communicate, and network with other studies and technicians to ensure scheduling efficiency. 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 with reading or computer‑literacy deficits when using the self‑administered web‑based study tool. Clarify questions that may arise from these self‑administered health surveys. Provide backup coverage for other CRCs, under supervision, in implementing HIV‑ or 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. Manage database structure for each protocol and 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 and 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. 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 (e.g., scheduling meetings, taking meeting minutes, filing, purchasing). Set up and maintain petty cash fund of up to \$2000 and manage gift‑card reimbursements, ensuring proper subject reimbursement procedures. Ensure appropriate and accurate charges are applied to the correct study fund; work directly with accounting to set up new systems for funding needs. Assist in the management of a complex network of vendors 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 protocols 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 protocol applications are submitted in a timely manner and act as liaison between CHR and study investigators. Provide quality assurance checks to note if protocols or UCSF CHR applications need modification; 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 verbal and written communication skills, and the ability to multi‑task in a fast‑paced environment 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 Experience using Qualtrics and/or Redcap for survey administration. Understanding of patient population to create rapport and provide realistic participation guidance. Experience communicating remotely with study participants (e.g., email, text, video chat); at least six months of survey research that includes sensitive content, or equivalent 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 and with transgender men and women. Experience working with culturally diverse groups. Spanish language proficiency. Comfortable discussing sensitive issues such as sexual practices. Demonstrated excellent attendance and reliability. Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality and HIPAA regulations, patient safety, and data management (including Redcap, Qualtrics, Stata, and/or R). Experience applying Good Clinical Practice Guidelines, HIPAA, Protection of Human Research Subjects, CHR regulations for recruitment and consent of research subjects, effective cash handling procedures, environmental health and safety training, and fire safety training. Fluency in the use of the Committee of Human Research (CHR) online iMEDris system for protocol submission, renewal, and modification. BA/BS or associate's degree. 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