Human Research Protection Program Manager
Job Code: 4933
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) Manager 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 Manager 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. The HRPP Manager 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 Manager must have a strong working knowledge of state and federal regulations pertaining to human participants in research and demonstrated leadership and mentoring skills. Familiarity with human research in academic institutions is highly desirable.
- Develop, implement, and manage efficient procedures to facilitate the processing 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 in the submission application and contacting the investigator orally or in writing to request additional materials.
- Plan and coordinate monthly IRB review and follow-up activities.
- 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.
- Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities.
- Lead special projects or meetings on complex issues; participate in multi- functional teams.
- Provide expertise in specialized compliance or scientific areas (e.g., gene transfer, HIV AIDS protocols, stem cells, clinical trials, research with vulnerable populations, transgenic, neurosciences, and animal husbandry).
- Manage the work of other employees, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring, as assigned.
* - Other duties may also be assigned
Education & Experience:
Bachelor’s degree and five 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.
- Comprehensive knowledge of regulatory information regarding the use of human participation in research and teaching.
- Demonstrated understanding of the principles of human research protection standards.
- Strong 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.
- 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 is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford welcomes applications from all who would bring additional dimensions to the University’s research, teaching and clinical missions.
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 the job.