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.

The Senior 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.

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 (ucop.edu)

Please note: The compensation ranges listed online for roles not covered by a bargaining unit agreement are very wide, however a job offer will typically fall in the range of 80% - 120% of the established mid-point. 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

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC or Cancer Center) is an interdisciplinary research center, part of a campus- wide multidisciplinary initiative with a goal of enhancing and integrating cancer related research and clinical care at UCSF. The Cancer Center is part of a network of 40 comprehensive cancer centers throughout the United States supported by the National Cancer Institute (NCI). It is led by a seven-member Directors Group and is comprised of 230 members working at the four major UCSF campus and hospital locations.

The HDFCCC Infrastructure is a program of the Cancer Center created to facilitate translational and clinical research focused on the development and use of new, safer, and more efficacious therapies for cancer treatment. The HDFCCC Infrastructure provides centralized services essential to cancer researchers across the spectrum. These services consist of several functional areas housed within the HDFCCC, including the DSMC, CRSO, and the PRMC, with oversight from the CCCROC oversight committee. This includes protocol development, scientific review, protocol compliance and patient safety, regulatory affairs, research personnel management, clinical research office, budgets and contracts office, and consultation in various scientific modalities. Cancer research programs across campus are encouraged to participate in the optional centralized services discussed above.

• Bachelor's degree in related area and / or equivalent experience / training
• Certification by the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP)
• A minimum of 3 years’ experience in clinical research as a study coordinator or equivalent experience in a pharmaceutical company.
• Demonstrated self-discipline and sound, independent judgment completing complex assignments.
• Proven advanced knowledge of good clinical practice guidelines, FDA regulations, and university policy and procedures in Human Experimentation.
• Proven ability to synthesis medical information and determine if the medical information within the medical records has been abstracted and recorded currently in the study database.
• Proven ability to understand oncology, the specific organ cancers, and the standard of care treatments, as well as new experimental drug and biologics.
• Proven ability to problem solve on the spot and determine if a medical event or non- compliance is significant and reportable to the supervisor or the Chair of the DSMC.

• A minimum of 2 years as Data Safety Monitor at an academic institution or 1 year at a pharmaceutical company
• RN License
• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
• Demonstrated proficiency in public speaking, and writing.
• Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.
• Experience with working with OnCore database
• Proven advanced knowledge of UCSF policy and procedures in Human Experimentation

Certification by the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP)

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.

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.

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.

Campus

006230 RSCH CMPLNC ANL 3

Professional and Managerial, Research and Scientific

99 - Policy-Covered (No Bargaining Unit)

Career

100%

Flexible (combination of onsite and remote work), Mission Bay (SF)

Days

8 Hours

Monday - Friday; 40 hours/week