Senior Human Research Protection Program Manager

Location
California, United States
Posted
16 Oct 2018
End of advertisement period
16 Dec 2018
Ref
79524
Contract Type
Permanent
Hours
Full Time

Description:

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 Sr. Human Research Protection Program (HRPP) Manager position within the Research Compliance Office (RCO). RCO is charged with ensuring that all aspects of Stanford University‚Äôs 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. 

As part of the RCO leadership team, the Sr. HRPP Manager 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. 

Responsibilities*:

Under the direction of the HRPP Associate Director, the Sr. HRPP Manager is charged with the smooth functioning of the HRPP through its day-to-day operation,

  • Lead and supervise IRB managers, including attending convened IRB meetings. 
  • High level review and oversight of protocols involving, e.g., high risk, vulnerable populations, and stem cell therapy and provides guidance to staff on complex regulatory issues. 
  • Serve as an alternate non-scientist IRB member on all panels.
  • Collaborate to ensure continuous quality improvement to maintain an effective compliance training program.
  • Act as a liaison with other groups within the Stanford HRPP 
  • Hires, manages, and on boards new staff and continuous development and growth of staff.
  • Monitors staff workloads to meet required metrics and identifies opportunities for improvement. 
  • Serves on subcommittee meetings for noncompliance investigations, as needed.
  • Participates in regulatory audits, as needed.

* - Other duties may also be assigned

MINIMUM REQUIREMENTS:

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).