Clinical Research Coordinator

Job Summary

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.

The final salary and offer components are subject to additional approvals based on UC policy.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)

Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Department Description

ABOUT DIVISION OF HIV, INFECTIOUS DISEASES AND GLOBAL MEDICINE

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.

Required Qualifications

• 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.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• 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 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
• 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

About UCSF

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.

Pride Values

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 our PRIDE values.

In addition to our PRIDE values, 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 at diversity.ucsf.edu

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Job Code and Payroll Title

009335 CLIN RSCH CRD

Job Category

Research and Scientific

Bargaining Unit

University Professional Technical Employees – Research Support Professionals Unit (UPTE-RX)

Location

Zuckerberg San Francisco General (ZSFG)

Additional Shift Details

Mon-Fri, 8AM – 5:00PM