DaVita Inc.
Assistant Director CTO Quality Assurance - 136130
DaVita Inc., San Diego, California, United States, 92154
Special Selection Applicants: Apply by 8/11/2025. Eligible Special Selection clients should contact their Disability Counselor for assistance.
While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required. DESCRIPTION The Quality Assurance (QA) Program is essential to the quality oversight activities at the Moores Cancer Center (MCC) Clinical Trials Office (CTO). This position manages operations, including administrative and budget functions, for the clinical research quality assurance program within the CTO. The goal is to ensure alignment with departmental objectives and institutional priorities. Reporting to the MCC CTO Senior Administrative Director, the Assistant Director of QA sets overarching research and operational goals and develops subordinate objectives to meet those goals. This role focuses on building and advancing a scalable QA infrastructure that supports high-impact oncology research, including investigator-initiated trials (IITs), industry-sponsored trials, and cooperative group studies. The position leads transformational initiatives in QA, such as strategy development, systems implementation, readiness for external regulatory inspections (including FDA audits), and integrating quality measures throughout the clinical trial lifecycle. The Assistant Director will establish and oversee an internal MCC CTO QA Team comprising auditors/monitors capable of evaluating clinical, regulatory, investigational product, data, and laboratory components. Collaborating closely with the CTO Medical Director, Disease Team Leaders, Regulatory Affairs, the Data and Safety Monitoring Committee (DSMC), and institutional leadership, the individual will develop and implement quality frameworks that meet or surpass internal and external regulatory standards. As an expert in cancer clinical trial quality assurance, this person applies advanced knowledge of clinical research protocols and processes to ensure rigorous, high-quality research conduct across MCC trials. The role includes managing operations, including administrative and budget responsibilities, for a clinical research initiative or program. It involves setting subordinate goals based on research objectives to ensure successful outcomes. MINIMUM QUALIFICATIONS
Advanced degree in a related field and/or equivalent experience/training. Seven (7) or more years of relevant experience. Comprehensive academic knowledge and practical experience in clinical research philosophy, applying theoretical concepts and industry best practices in trial settings. Proven ability to translate clinical research philosophy into clinical input for trial design, planning, initiation, execution, and reporting. Extensive knowledge of clinical research concepts, laws, regulations, and industry standards governing clinical trials, along with safety standards and regulations. Broad understanding of all phases of clinical research, from startup to closeout and dissemination, including complex trial designs. Proven management skills in supervising and developing clinical staff, mentoring professionals, and conducting performance reviews. Ability to manage multiple priorities effectively. Ability to collaborate with cross-functional teams and diverse educational backgrounds. Skilled in interfacing with commercial, regulatory, federal, and study team members, with persuasive influence skills. Excellent problem-solving and analytical skills; capable of addressing complex or novel issues creatively and efficiently. Strong communication skills, including verbal and written, active listening, critical thinking, and advising. Proficiency in data analysis and strategic presentation for various audiences. Exceptional organizational skills to streamline research functions and improve staff and trial organization. Expertise in using campus clinical information and documentation systems, with proficiency in project management software. PREFERRED QUALIFICATION
Experience within the UC System. SPECIAL CONDITIONS
Flexibility to work various hours and locations based on business needs. Employment contingent upon passing a criminal background check. Pay Transparency Act Annual Full Pay Range: $116,000 - $224,200 (pro-rated if less than 100% appointment) Hourly Range: $55.56 - $107.38 The actual salary will depend on experience, skills, education, certifications, and organizational needs. The posted salary range reflects the budgeted pay scale, which may be broader due to internal equity, budget constraints, and bargaining agreements.
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While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required. DESCRIPTION The Quality Assurance (QA) Program is essential to the quality oversight activities at the Moores Cancer Center (MCC) Clinical Trials Office (CTO). This position manages operations, including administrative and budget functions, for the clinical research quality assurance program within the CTO. The goal is to ensure alignment with departmental objectives and institutional priorities. Reporting to the MCC CTO Senior Administrative Director, the Assistant Director of QA sets overarching research and operational goals and develops subordinate objectives to meet those goals. This role focuses on building and advancing a scalable QA infrastructure that supports high-impact oncology research, including investigator-initiated trials (IITs), industry-sponsored trials, and cooperative group studies. The position leads transformational initiatives in QA, such as strategy development, systems implementation, readiness for external regulatory inspections (including FDA audits), and integrating quality measures throughout the clinical trial lifecycle. The Assistant Director will establish and oversee an internal MCC CTO QA Team comprising auditors/monitors capable of evaluating clinical, regulatory, investigational product, data, and laboratory components. Collaborating closely with the CTO Medical Director, Disease Team Leaders, Regulatory Affairs, the Data and Safety Monitoring Committee (DSMC), and institutional leadership, the individual will develop and implement quality frameworks that meet or surpass internal and external regulatory standards. As an expert in cancer clinical trial quality assurance, this person applies advanced knowledge of clinical research protocols and processes to ensure rigorous, high-quality research conduct across MCC trials. The role includes managing operations, including administrative and budget responsibilities, for a clinical research initiative or program. It involves setting subordinate goals based on research objectives to ensure successful outcomes. MINIMUM QUALIFICATIONS
Advanced degree in a related field and/or equivalent experience/training. Seven (7) or more years of relevant experience. Comprehensive academic knowledge and practical experience in clinical research philosophy, applying theoretical concepts and industry best practices in trial settings. Proven ability to translate clinical research philosophy into clinical input for trial design, planning, initiation, execution, and reporting. Extensive knowledge of clinical research concepts, laws, regulations, and industry standards governing clinical trials, along with safety standards and regulations. Broad understanding of all phases of clinical research, from startup to closeout and dissemination, including complex trial designs. Proven management skills in supervising and developing clinical staff, mentoring professionals, and conducting performance reviews. Ability to manage multiple priorities effectively. Ability to collaborate with cross-functional teams and diverse educational backgrounds. Skilled in interfacing with commercial, regulatory, federal, and study team members, with persuasive influence skills. Excellent problem-solving and analytical skills; capable of addressing complex or novel issues creatively and efficiently. Strong communication skills, including verbal and written, active listening, critical thinking, and advising. Proficiency in data analysis and strategic presentation for various audiences. Exceptional organizational skills to streamline research functions and improve staff and trial organization. Expertise in using campus clinical information and documentation systems, with proficiency in project management software. PREFERRED QUALIFICATION
Experience within the UC System. SPECIAL CONDITIONS
Flexibility to work various hours and locations based on business needs. Employment contingent upon passing a criminal background check. Pay Transparency Act Annual Full Pay Range: $116,000 - $224,200 (pro-rated if less than 100% appointment) Hourly Range: $55.56 - $107.38 The actual salary will depend on experience, skills, education, certifications, and organizational needs. The posted salary range reflects the budgeted pay scale, which may be broader due to internal equity, budget constraints, and bargaining agreements.
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