If you have experience with regulatory affairs and the protection of human or animal subjects in research, you may be the right match for this Sr. Quality Manager position in the Research Compliance Office (RCO). RCO is charged with ensuring that all aspects of the Human Research Protection Program (HRPP) and the Institutional Animal Care and Use Program (IACUP) comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. This position is core to Stanford’s research compliance activities.
Under the direction of the Associate Director for Program Development, the Sr. Quality Manager will partner closely with Research Compliance Office (RCO) leadership to promote a culture of process improvement in support of RCO’s mission. The incumbent will develop strategies to enhance efficiencies and streamline existing processes with an eye for consistency wherever possible, collaborate with staff to identify opportunity for improvements, and measure the quality and integrity of services delivered. In addition, the Sr. Quality Manager will be the steward of official documents and procedures to facilitate record management and document control. Other duties may include serving as an expert contact with research investigators and administrators; educating parties on relevant and emerging regulations, and supporting educational activities.
Develop, implement, and manage process improvement to facilitate the review of human/animal research protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.
Perform review of complex research protocols, including identifying problems and issues. Recommend, design, and conduct reviews as necessary to ensure improvements are implemented
Plan and coordinate monthly IRB/IACUC review and follow-up activities in order to drive consistency and streamlining effort throughout RCO. Advise on and support standardization and streamlining of processes wherever possible and appropriate, in line with best practices to ensure accuracy and compliance.
Serve as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
Apply knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance. Ensures HRPP and IACUP are in compliance with federal regulations, state laws, and Stanford policies. Manage official documents and procedures for easy updates, maintenance, and retrieval.
Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities. Advise RCO leadership on strategies for campus outreach and readiness, education and monitoring
Lead special projects or meetings on complex issues; participate in multifunctional teams, and assist in implementing solutions in the various RCO groups
May manage the work of other employees, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring, as assigned.
*Other duties as assigned
Minimum Requirements, Education -Experience
Four year college or equivalent
Five years job related experience
Minimum Knowledge, Skills and abilities required of the position
Comprehensive knowledge of regulatory information regarding the use of human/animal participation in research and teaching
Demonstrated understanding of the principles of Human/Animal research protection standards
Strong knowledge of grants and contracts function
In-depth understanding of operational requirements pertaining to management and implementation of protocol process
Strong communication and presentation skills (verbal and written)
Demonstrated analytical skills
Direct IRB or IACUC experience, preferably with an AAHRPP or AAALAC accredited institution. Advanced knowledge of human subjects/animal protection regulations and best practices, as evidenced by certification (e.g., ability to obtain or retain IRB or IACUC professional )
Significant working knowledge of research procedures and terminology, medical terminology, clinical trials and research data management
Knowledge of medical/scientific areas such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, epidemiology
Stanford University, located between San Francisco and San Jose in the heart of California's Silicon Valley, is one of the world's leading teaching and research universities. Since its opening in 1891, Stanford has been dedicated to finding solutions to big challenges and to preparing students for leadership in a complex world.
Supporting that mission is a staff of more than 10,000, which is ro...oted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.