Quality Assurance Officer
UC Davis Comprehensive Cancer Center
November 10, 2021
Quality Assurance Officer – Sacramento Campus
The UC Davis Cancer Care Network (CCN) is a national model for optimizing integrated, collaborative cancer care. The Cancer Care Network extends the UC Davis Comprehensive Cancer Center (UCDCCC) to community cancer centers throughout Northern and Central California providing leadership, clinical care, research, clinical trials and education for diverse communities.
Final Filing Date
$2612.80 - $5245.60
We offer exceptional employment benefits including medical, dental, and vision plans, generous paid vacations and holidays, excellent retirement savings and investment plans, continuing education, and reduced fee and scholarship programs.
THIS IS NOT AN H1- B OPPORTUNITY
The Quality Assurance Officer (QAO) works closely with UCDCCC CCN leadership and staff, sponsors and Investigators to address compliance challenges and issues. In this position, the incumbent will be responsible for developing and implementing a comprehensive quality assurance program in the context of CCN clinical trials management. The QAO builds and maintains a culture of excellence, safety, and compliance with the goal of achieving an audit-ready operation at all times.
In addition, the QAO helps scale and implement clinical research training programs and will be responsible for the development, management, and organization of training programs. The role includes researching and creating content and tools to streamline protocol driven activities, building a curriculum that ensures the highest quality of care through education, hands-on training, and information sharing through various mediums. The incumbent establishes and monitors quality metrics and determines how best to maintain high standards of performance.
Five years of professional experience in a health care or academic setting with a minimum of two years’ experience with research protocols and regulatory compliance.
Experience with monitoring or auditing FDA regulated studies for highly complex clinical trials.
Strong understanding of clinical research conduct (GCP, ICH guidelines) with knowledge of both current standard and novel investigational therapies in multiple therapeutic areas across Phase I, II & III trials.
Experience reviewing/verifying the timely and accurate submission of clinical trial data, reporting findings and proposing quality improvements
Experience developing protocol training/education materials as well as protocol implementation materials and tools to assure high level of compliance with the protocol driven research activities
Ability to identify areas of operational weakness and work with clinical research leadership to propose and implement improvement initiatives
Demonstrates advanced knowledge of computer operating systems and proficiency with word processing, spreadsheet, database, and graphics software.
Ability to perform analyses and present data and information in clear and concise report formats. Uses performance improvement evaluation methods, tools and techniques of problem-solving and group dynamics management when implementing changes identified through quality assurance efforts.
Analytical skills to solve complex problems and to investigate various sources of information and techniques and develop acceptable solutions
Administrative skills and ability to exercise good judgment, initiative, and resourcefulness.
Analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and/or approaches.
Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline driven environment.
Analytical skills to independently and proficiently assume responsibility for coordination and completion of complex projects requiring interactions with parties in an organizational structure. Ability to work with multiple external parties in a professional manner as a representative of the CCN, Office of Clinical Research, UCDCCC, and the University of California, Davis.
Ability to prepare written materials of a diverse nature using correct grammar, effective diction, correct spelling, and appropriate form to establish good rapport with the general public, co-workers, physicians, patients, caregivers, clinic staff, and other health care professionals.
Ability to work occasional overtime as work demands.
Society of Clinical Research Administrators (SoCRA) or Association of Clinical Research Professions (ACRP) certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research) or equivalent
Experience in cancer field preferred.
Experience with cancer-related research
Knowledge of various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored)
This position may be subject to a criminal background investigation, drug screen, Live Scan fingerprinting, medical evaluation clearance, and functional capacity assessment.
The University of California has implemented a SARS-CoV-2 (COVID-19) Vaccination Program SARS-CoV-2 Vaccination Policy (ucop.edu) covering all employees. To be compliant with the policy, employees must submit proof of vaccination or a University-approved exception or deferral.
The University of California is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.