Human Research Protection Program Assistant Director
Job Code: 4936
Are you an accomplished professional interested in supporting research? Do you have experience managing and mentoring a team? Do you enjoy regulatory compliance and providing excellence in customer service? Can you remain highly organized and detailed oriented in a fast-paced, priority-shifting environment?
If yes, consider applying for the Human Research Protection Program (HRPP) Assistant Director position within the Research Compliance Office (RCO). RCO is charged with ensuring that all aspects of Stanford University’s research activities involving human subjects or stem cells comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining full certification status.
Under the direction of the HRPP Associate Director, the HRPP Assistant Director is charged with the smooth functioning of the HRPP through its day-to-day operation, including managing a team of IRB Managers, providing guidance and oversight on complex issues, and attending weekly convened IRB meetings to ensure consistency in protocol review, policy interpretation, and IRB panel organization. The HRPP Assistant Director will serve as an alternate non-scientist IRB member on all panels, and collaborate with the CQI team to ensure continuous quality improvement to maintain an effective program.
As part of the RCO leadership team, the HRPP Assistant Director must have a strong working knowledge of state and federal regulations pertaining to human subjects research and demonstrated leadership and mentoring skills. Familiarity with human research in academic institutions is highly desirable.
- Develop and ensure implementation of policies and procedures, particularly those mandated by accrediting bodies.
- Evaluate emerging regulatory requirements, and advise on the appropriate institutional response.
- Develop and maintain senior level internal and external relationships with a range of contacts (e.g., Stanford, other university affiliated entities, and federal, state, and local agencies) to represent the HRPP IRB interests and promote research compliance.
- Ensure program accountability for federally mandated research review committees and maintaining compliance with federal, state, and local regulations applicable to research projects involving human participants.
- Provide advice and leadership on complex risk management issues.
- Ensure all operational activities related to protocol activities involving human participants in medical and non-medical research meet timely achievement of goals.
- Manage the work of other employees, recommending hiring or disciplinary actions or providing coaching, training and mentoring. Determine staffing needs and make hiring or firing decisions, as needed, with final approval from director/deputy director.
* - Other duties may also be assigned
Education & Experience:
Bachelor's degree and seven years of relevant experience, or combination of education and relevant experience.
Knowledge, Skills and Abilities:
- Demonstrated strong verbal and written communication skills.
- Excellent customer service skills and ability to use tact and discretion.
- Strong leadership and management skills.
- Expert knowledge of regulatory information regarding the use of human participation in research and teaching.
- Demonstrated understanding of the principles of human research protection standards.
- Expert knowledge of grants and contracts function.
- Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.
- In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
- Demonstrated strategic oversight experience.
- Advanced knowledge of human subjects protection regulations and best practices, as evidenced by certification (e.g., Certified IRB Professional).
- Knowledge of medical/scientific areas, such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, and epidemiology.
- Direct research compliance experience.
Certifications and Licenses:
- Ability to obtain or retain Institutional Review Board professional certification (e.g., CIP).
Stanford University is an equal employment opportunity and affirmative action employer and is committed to recruiting and hiring qualified women, minorities, protected veterans and individuals with disabilities.
- Schedule: Full-time
- Job Code: 4936
- Employee Status: Regular
- Grade: L