Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. While HIV pre-exposure prophylaxis (PrEP) effectively reduces HIV acquisition risk, it does not address the surge in bacterial STIs. The DoxyPEP Study has demonstrated the efficacy of Doxycycline post-exposure prophylaxis (PEP) among sexual minority men and transgender women. However, puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan dPEP study. Preliminary data from dPEP show low detection of doxycycline among participants, suggesting that low medication adherence may explain the null result. As was needed for HIV PrEP to establish the relationship between patterns of pill-taking and drug concentrations, a directly observed therapy (DOT) study, the gold-standard approach to determine the pharmacology of doxy and establish pill-taking cut-offs, is needed. We will enroll 48 participants (12 cisgender men, 12 cisgender women, 12 transgender men on testosterone therapy, 12 transgender women on estrogen therapy) for a randomized cross-over DOT study, with in-depth pharmacokinetic measurement while dosing and during washout. When combined with sexual behavior data in the trials conducted in MSM/TGW and cisgender women, doxycycline PEP coverage of sexual acts and pharmacodynamic relationships can be established. This work will establish thresholds of doxycycline levels in hair, urine, and plasma to interpret doxycycline PEP adherence in roll-out studies in the future.
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.
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