Clinical Research Coordinator
About The Position
This position is for a Clinical Research Coordinator for the MucoCept-CVN Study, an NIH-funded first-in-human phase 1 clinical trial testing the safety, colonization, acceptability, and clearance of a live biotherapeutic product for the prevention of HIV. The study involves up to three doses of MucoCept-CVN in 12 participants. The coordinator will act independently and be the primary recruiter, screening, enrolling, and conducting all study visits under the direction of the principal site investigator. Responsibilities include data management, report generation, specimen collection and transportation, IRB requests, and coordinating the work of other staff. The role also involves acting as an intermediary between UCSF and the study sponsor DAIDS, coordinating staff schedules, assisting with intern training, ensuring regulatory compliance, overseeing data integrity, implementing quality control procedures, maintaining regulatory documents, reporting study progress, and performing other assigned duties. This position is part of the Department of Obstetrics, Gynecology, & Reproductive Sciences (ObGyn & RS) at UCSF, specifically within the Bixby Center for Global Reproductive Health at the San Francisco General Hospital (SFGH) Division. The department is committed to quality healthcare, education, and research in women's health, with a mission to promote justice, quality, and equity in women's healthcare and eliminate barriers to good health. The Bixby Center focuses on global reproductive and sexual health research and training, aiming to improve access to reproductive health services and HIV/STI treatment worldwide.
Requirements
- Perform independently
- Act as the primary recruiter
- Screen participants
- Enroll participants
- Conduct study visits
- Data management
- Generating reports
- Specimen collection and transportation
- IRB requests
- Coordinate staff work schedules
- Assist with training of interns
- Assure compliance with regulatory agencies
- Oversee study data integrity
- Implement and maintain quality control procedures
- Maintain regulatory documents
- Report study progress to investigators
Nice To Haves
- Experience with NIH-funded clinical trials
- Experience with first-in-human studies
- Familiarity with live biotherapeutic products
- Knowledge of HIV prevention research
- Experience in Obstetrics, Gynecology, & Reproductive Sciences research
- Experience with the Bixby Center for Global Reproductive Health's mission
Responsibilities
- Perform independently and act as the primary recruiter for a clinical research study.
- Screen, enroll, and conduct all study visits as directed by the principal site Investigator.
- Support the overall study with data management, generating reports, specimen collection and transportation, and IRB requests.
- Coordinate the work of the nurse practitioner and study interns.
- 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.
- Perform other duties as assigned.
Benefits
- Reasonable accommodation(s) for qualified individuals with disabilities are available as part of the application and interview processes.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
