Human Research Protection Program (HRPP) Regulatory Manager

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Compliance Legal
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86487 Requisition #
Human Research Protection Program (HRPP) Regulatory Manager (Research Compliance Manager 1)
Job Code: 4932
Grade: J

If you have experience with regulatory compliance and institutional review boards (IRBs) and have excellent customer service skills, you may be the right match for this Human Research Protection Program (HRPP) Regulatory Manager position. We are looking for bright, intellectually curious individuals who are self-driven and highly organized to join the Stanford University HRPP. The HRPP Regulatory Manager position within the RCO collaborates with other research entities within Stanford and helps the HRPP comply with all applicable laws, regulations, and policies.

Under the direction of the HRPP Associate Director, the HRPP Regulatory Manager is responsible for:
  • Collaborating with IRB staff and the Continuous Quality Improvement team to identify areas for monitoring, process improvements, policy and procedure development or revision, and education
  • Implementing a comprehensive education and training program that serves RCO HRPP staff, IRB members, and Stanford’s research community
  • Maintaining and updating the HRPP policies and procedures to be consistent with federal and state regulations, institutional policy, and accreditation standards
  • Assisting in ongoing accreditation efforts
  • Appling advanced knowledge and in-depth understanding of federal, state, and local regulations and university policies to maintain an ongoing and proactive education and training program
  • Leveraging technology to deliver education programs in the most efficient way to a wide variety of audiences.

Core Duties:
  • Develop, implement, and manage efficient procedures to facilitate the processing of human 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 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.

To be successful in this position, you will bring:
  • Bachelor’s degree and three years of relevant experience, or combination of education and relevant experience.
  • Excellent customer service skills and ability to use tact and discretion.
  • Comprehensive knowledge of regulations and ethical principles regarding human subjects in research.
  • Demonstrated understanding of research procedures terminology, medical terminology, clinical trials, and research data management.
  • In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
  • Strong knowledge of grants and contracts function.
  • Demonstrated strong verbal and written communication skills.

In addition, our preferred requirements include:
  • Institutional Review Board Professional Certification (CIP)

Physical Requirements:
  • 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 the job.

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
  • Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
  • A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
  • A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
  • Discovery and fun. Stroll through historic sculptures, trails, and museums.
  • Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more!

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

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.

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