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. 
 

 

 

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 - Experience using Qualtrics and/or Recap 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 HIPPA 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. - BA/BS or Associate’s degree.

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as https://www.ucsf.edu/about/mission-and-values . In addition to , UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available https://diversity.ucsf.edu/ . Join us to find a rewarding career contributing to improving healthcare worldwide.

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.