Clinical Research Coordinator

MucoCept-CVN Study
UCSF is conducting an NIH-funded first-in-human phase 1 clinical trial testing safety, colonization, acceptability and clearance of a live biotherapeutic product (MucoCept-CVN) for the prevention of HIV.
MucoCept-CVN contains Lactobacillus bacteria that are naturally found in a healthy vagina and were genetically modified to Lactobacillus jensenii 1153-1666 which secretes an antiviral protein called cyanovirin designed to prevent HIV. When these bacteria live and grow in the vagina, they reproduce the built-in antiviral protein. The study is assessing the use of up to three doses of MucoCept-CVN in 12 participants.
 

The SF-based clinical research coordinator will perform independently and act as the primary recruiter for a clinical research study. As directed by the principal site Investigator, the clinical research coordinator will screen, enroll, and conduct all study visits. S/he will support the overall study with data management, generating reports, specimen collection and transportation, IRB requests, and coordinates the work of the nurse practitioner and study interns.
 

Further, the clinical research coordinator will act as intermediary between UCSF and the study sponsor DAIDS,
coordinate staff work schedules, assist with training of interns, help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; maintain all regulatory documents; report study progress to investigators; and perform other duties as assigned.
 

This position is in the Department of Obstetrics, Gynecology, & Reproductive Sciences (ObGyn & RS), a major
academic department in the School of Medicine committed to providing quality health care services, educating
health care providers and investigators, and conducting research to advance knowledge in our field. The
Department is nationally recognized for research and training in women’s health care specialties. This position is based at the Department’s San Francisco General Hospital (SFGH) Division, a large teaching, research, and clinical site. The SFGH Division of Ob-Gyn & RS is home to ~40 faculty, 8 non-faculty academics, and 110 staff; fellows, residents, and other trainees; and the Bixby Center for Global Reproductive Health. The SFGH division has an annual budget of over $70M. Our mission in the SFGH Division of Ob-Gyn & RS is to promote justice, quality, and equity in women's health care. We seek to eliminate barriers to good health for women in San Francisco and around the world. We are committed to building and supporting a diverse and inclusive workplace and strive to understand and address the impact of structural inequities on sexual and reproductive health.
 

This position is an integral part of the Bixby Center for Global Reproductive Health which is situated within the
ZSFG Division of Ob-Gyn & RS. The Bixby Center leads research and training programs around the world to
improve reproductive and sexual health. We work to ensure that all people have access to birth control, abortion, sex education, pregnancy and birth care and HIV/STI treatment—regardless of their age, ethnicity, income, or where they live. Our 200+ members advance reproductive health policy and practice worldwide through research, training and advocacy. Since the Bixby Center’s founding in 1999, our research has changed policy, clinical care and laws for the better. Our work informs evidence-based reproductive and sexual health policies, treatment and care guidelines to save women’s lives around the world.

Reasonable accommodation(s) to qualified individuals with disabilities are available as part of the application and interview processes. If you would like to request accommodations, please contact the recruiter or hiring manager. If workplace accommodations are needed after a job offer is made, please contact the supervisor and/or Disability Management Services (DMS) at (415) 476-2621 to initiate the interactive process.

Required Qualifications: - Excellent attention to detail; highly organized and efficient; strong interpersonal skills; excellent, effective verbal, over-the-phone 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. - Possess technical knowledge in the areas of health research, regulatory and ethical review board guidelines, interview administration. - Good understanding of the health context in which study takes place - Advanced knowledge of Microsoft Office, including word, powerpoint, excel; familiarity with Access Preferred Qualifications: - Bachelor’s Degree strongly preferred - MPH or other degree in health sciences preferred - Fluency in the usage of the IRB online iMEDris system for submission, renewal, and modification of protocols through this system. - Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation. - Experience with recruitment via websites, electronic community board postings, etc. - Knowledge of UCSF and departmental policies for dealing with reimbursement, procurements, 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: - Access, Stata, SASS/ SPSS, and Teleform programming platforms. - 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