Are you interested in supporting research? Are you customer-service oriented? Do you have experience with regulatory affairs? Are you highly organized and detailed oriented?
If yes, consider applying for the position of Associate Director for Policy Development (RCM3) position within the Research Compliance Office (RCO). RCO is charged with ensuring that all aspects of Stanford research activities involving human subjects, animal subjects or stem cells comply with applicable laws, regulations, and policies, including standards of excellence necessary for maintaining full certification status.
Specific responsibilities include:
Working closely with the Research Compliance Office (RCO) Director and the RCO leadership team, the Associate Director for Policy Development will have a lead role in policy analysis and development. The incumbent will use advanced knowledge of the national and state regulatory framework, and thorough understanding of the intricacies of human research protection program, to provide expert advice on federal, state, and University Policy and emerging regulatory requirements, interact effectively with regulatory agencies, and guide the development of HRPP policies and procedures. In addition, this person will collaborate with the Associate Director for the Institutional Animal Care and Use Program on areas of mutual interest. This work may impact Stanford’s research community at large, and influence the regulatory landscape through collaboration with peer institutions and national organizations. This person must respond quickly to changing direction, and focus and embrace the vision for the RCO to facilitate consistency of practice wherever possible. 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/IACUC 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 animal or human participants in medical and non-medical research meet timely achievement of goals.
May manage the work of other employees, recommending hiring or disciplinary actions or providing coaching, training and mentoring.
* - 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.
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.
Strong leadership and management skills.
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 or Institutional Animal Care and Use Committee professional certification (CIP; CIPIA).
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.