Senior Data Safety Monitor (Clinical Research Associate)
University of California San Francisco
Location: San Francisco, California
Internal Number: 64246BR
The Senior Data Safety Monitor (Clinical Research Associate)will be responsible for conducting the monitoring/auditing of the Phase I, II and III Investigator-Initiated trials in the Cancer Center under the direction of the DSMC Monitor/CRA Supervisor.. These monitoring/auditing visits will be conducted according to Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), the UCSF IRB, and the UCSF DSMP. The Senior DSM will also be on-call for Phase I monitoring of Investigator Initiated trials that will require review of safety data, including Dose Limiting Toxicities (DLTs), prior to dose escalations.
The Senior Data Safety Monitor (Clinical Research Associate)will be responsible for yearly Regulatory Audits for the Investigator-Initiated Trials ensuring that these files comply with IRB, FDA, GCP and UCSF requirements, conducting audits of the regulatory and patient charts for Industry-Sponsored Quality Assurance Audits, National Cancer Institute (NCI) Audits, as well as FDA Inspections, identifying issues of non-compliance and/ or significant finding during the monitoring/auditing visits, and communicating these findings to the DSMC Director and DSMC Chair (or Vice Chair) in an expedited manner.
TheSenior Data Safety Monitor (Clinical Research Associate)will be responsible for attending the DSMC Meetings, which occur every eight weeks and will assist with the agenda and minutes for these meetings.
**Note: This position is remote with occasional on-site work at the Mission Bay campus.
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 high-quality patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.