safety manager California
UC San Francisco
Full Time
California
10.56 - 12.04 USD Today
Job description
The Data Safety Auditor (DSA) will be responsible for conducting the auditing of the Phase II and III Investigator-Initiated trials (IITs) in the Cancer Center under the direction of the DSMC Auditor Supervisor. These auditing visits will be conducted according to Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), the UCSF IRB, and the UCSF Data and Safety Monitoring Plan (DSMP).
The DSA will be responsible for biennial Regulatory Audits for the Investigator-Initiated Trials in order to ensure that these files comply with IRB, FDA, GCP and UCSF requirements.
The DSA will be responsible for conducting audits of the participant charts for non-therapeutic studies, as well as the audits of low to moderate risk therapeutic studies. Additionally, the DSA will be responsible for assisting with audit and inspection preparation for Industry-Sponsored Quality Assurance Audits and FDA Inspections.
The DSA will be responsible for identifying issues of non-compliance and/ or significant findings during auditing visits and is responsible for communicating these findings to their supervisor, the DSMC Director and DSMC Chair (or Vice Chair) in an expedited manner.
The DSA will be responsible for attending the DSMC Meetings, and will assist with the agenda, minutes, and facilitation for these meetings.
The DSA will be responsible for biennial Regulatory Audits for the Investigator-Initiated Trials in order to ensure that these files comply with IRB, FDA, GCP and UCSF requirements.
The DSA will be responsible for conducting audits of the participant charts for non-therapeutic studies, as well as the audits of low to moderate risk therapeutic studies. Additionally, the DSA will be responsible for assisting with audit and inspection preparation for Industry-Sponsored Quality Assurance Audits and FDA Inspections.
The DSA will be responsible for identifying issues of non-compliance and/ or significant findings during auditing visits and is responsible for communicating these findings to their supervisor, the DSMC Director and DSMC Chair (or Vice Chair) in an expedited manner.
The DSA will be responsible for attending the DSMC Meetings, and will assist with the agenda, minutes, and facilitation for these meetings.
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
Department Description
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 71 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 235 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, Clinical Research Support Office (CRSO), Clinical Research Network Office (CRNO) and the Protocol Review and Monitoring Committee (PRMC), with oversight from the Cancer Center Clinical Research Oversight Committee (CCCROC). This includes protocol development, scientific review, protocol compliance patient safety, regulatory affairs, research personnel management, budgets and contracts, and consultation in various scientific modalities. Cancer research programs across campus are encouraged to participate in the optional centralized services as discussed above.
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, Clinical Research Support Office (CRSO), Clinical Research Network Office (CRNO) and the Protocol Review and Monitoring Committee (PRMC), with oversight from the Cancer Center Clinical Research Oversight Committee (CCCROC). This includes protocol development, scientific review, protocol compliance patient safety, regulatory affairs, research personnel management, budgets and contracts, and consultation in various scientific modalities. Cancer research programs across campus are encouraged to participate in the optional centralized services as discussed above.
Required Qualifications
- Bachelor's degree in related area and / or equivalent experience / training and 1+ years related experience.
- A minimum of 1 year experience in clinical research or equivalent experience in a pharmaceutical company.
- 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.
- Independence, planning and decision-making abilities to complete assigned duties.
- Knowledge of relevant Federal and State regulations, and policies. Proven knowledge of good clinical practice (GCP) guidelines, FDA regulations, and university policy and procedures.
- Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.
- Effective, efficient and tactful oral and written communication skills.
- Time management skills and the flexibility to accommodate changing priorities in unit.
- Ability to work in a team-oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
- Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
- Excellent customer service skills, pleasant, helpful and patient.
- Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
Preferred Qualifications
- Relevant compliance certification (if applicable) preferred.
- SoCRA or ACRP Certification.
- Proven ability to understand oncology, the specific organ cancers, and the standard of care treatments, as well as new experimental drug and biologics.
- Knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
- Demonstrated proficiency in public speaking, and writing.
- Experience with working with OnCore database.
- Proven knowledge of UCSF policy and procedures.
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.
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.
Organization
Campus
Job Code and Payroll Title
006229 RSCH CMPLNC ANL 2
Job Category
Professional and Managerial, Research and Scientific
Bargaining Unit
99 - Policy-Covered (No Bargaining Unit)
Employee Class
Career
Percentage
100%
Location
Flexible (combination of onsite and remote work), Mission Bay (SF)
Shift
Days
Shift Length
8 Hours
Additional Shift Details
Monday - Friday; 40 hours/week; Hybrid - Remote & onsite as needed
About UC San Francisco
CEO: Samuel Hawgood
Revenue: $25 to $100 million (USD)
Size: 10000+ Employees
Type: College / University
Website: www.ucsf.edu
Year Founded: 1864
