Penn Foster
Junior Data and Safety Auditor
Penn Foster, San Francisco, California, United States, 94199
Junior Data and Safety Auditor (DSA)
The
Junior Data and 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.
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.
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 synthesize medical information and determine if the medical information within the medical records has been abstracted and recorded correctly 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, 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.Ability to work in a team-oriented setting, prioritize work, and 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.
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.
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
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The
Junior Data and 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.
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.
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 synthesize medical information and determine if the medical information within the medical records has been abstracted and recorded correctly 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, 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.Ability to work in a team-oriented setting, prioritize work, and 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.
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.
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
#J-18808-Ljbffr