Are you interested in contributing to novel research and discoveries in medicine and the social sciences? If yes, consider joining Stanford University – one of the world’s leading research universities. We are looking for bright, intellectually curious individuals who are self-driven and highly organized to join the Stanford University Research Compliance Office (RCO). The Assistant Director, Quality and Education is a key position within the RCO, whose mission is to ensure that Stanford conducts its human, stem cell, and animal research activities in compliance with a complex web of regulatory requirements and with integrity. This position collaborates directly with the Institutional Review Board (IRB) / Human Research Protection Program (HRPP), Institutional Animal Care and Use Committee (IACUC), and Stem Cell Research Oversight (SCRO) Committee. The Assistant Director, Quality and Education must have strong oral and written communication skills with demonstrated knowledge of regulatory affairs.
Under the general direction of the RCO Associate Director for Program Development, the Assistant Director, Quality and Education responsibilities include: (1) supervising a subset of RCO staff, (2) providing leadership to the regulatory compliance activities, and (3) managing the RCO process improvement projects. The Assistant Director, Quality and Education will:
Manage RCO process improvement projects, develop policies and procedures, and direct implementation activities, develop improvement measures based on outcomes and ensure consistency of performance.
Evaluate best ways to operationalize and train on new regulatory requirements.
Manage RCO knowledge base and documentation, and coordinate data for internal or external reporting.
Act as a liaison with eProtocol (RCO online submission and review system), identifying upgrades to eProtocol based on regulatory requirements and performance initiatives, and aiding in user support activities.
Direct and manage the work of Quality and Compliance Managers, providing, training, mentoring, and recommending hiring or disciplinary actions.
Education & Experience:
Bachelor's degree and seven years of relevant experience, or combination of education and relevant experience.
Knowledge, Skills and Abilities:
Strong leadership and management skills.
Demonstrated strong verbal and written communication skills.
Demonstrated strategic oversight experience.
Expert knowledge and understanding of regulatory information and standards pertaining to human or animal research protection.
In-depth understanding of operational requirements pertaining to management and implementation of protocol process; familiarity with contract and grant functions
Knowledge of medical/scientific areas, such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, and epidemiology.
Direct Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) experience with an accredited institution preferred.
Certifications and Licenses:
Ability to obtain or retain IRB or IACUC professional certification.
Frequently perform desk based computer tasks, seated work and use light/ fine grasping.
Occasionally stand, walk, and write by hand, lift, carry, push pull objects that weigh up to 10 pounds.
* Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
May work extended or non-standard hours based on project or business needs. Occasional cross campus and local travel may be required.
May be exposed to allergens, biohazards, chemicals, radiation or electromagnetic fields.
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
Internal Number: 83449
About Stanford University
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 rooted 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.