IRB Manager

SCHOOL/UNIT DESCRIPTION:

Who are we?

The Research Compliance Office (RCO) is responsible for oversight and management of Stanford's Administrative (Compliance) Panels and ensures compliance with applicable policies, accreditation standards and external regulations. Our goal at RCO is to help facilitate research and to make sure it is done safely, ethically, and legally. We take pride in being service-oriented.

Stanford University's IRB is charged with ensuring that all aspects of Stanford's Human Research Protection Program comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. This position, which is core to Stanford's research compliance activities, focuses primarily with medical Research.

We are seeking a candidate experienced with regulatory compliance and institutional review boards (IRBs) and that has excellent customer service skills.

Our VPDoR Diversity Journey:

• We create a hub of innovation through the power of diversity of disciplines and people.
• We provide equitable access and opportunity to all members of the community in order to do their best work, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
• We listen to and value all colleagues who bring diverse perspectives to the advancement and development of a respectful community.
• We promote a culture of belonging, equity, and safety.
• We embed these values in excellence of education, research, and operation.

POSITION SUMMARY:

In this position of IRB Manager (RCM1), under the direction of the Sr. IRB Manager and the IRB Chair, you will conduct in-depth protocol review using advanced regulatory knowledge and experience. The primary responsibility will be to manage the protocol review process and identify issues, and to independently determine whether the components of the proposed research are in compliance with federal, state and local regulations, Stanford University policies, and accreditation standards.

You will also be involved in:

• Developing, implementing, and managing efficient procedures to facilitate the processing of human protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.
• Performing 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.
• Planning and coordinating IRB review and follow-up activities.
• Serving as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
• Applying knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance.
• Providing assistance to management in preparation for accreditation and in various compliance and quality assurance activities.

This position will have the potential for a remote work arrangement based on operational needs and final candidate qualifications at the time of hire.

* Please note this position may require the following:

• Occasional work on evenings and weekends or on-standard hours based on project or business needs.
• Occasional cross campus and local travel
• Exposure to allergens, biohazards, chemicals, radiation or electromagnetic fields.

* - 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.

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.
• Comprehensive knowledge of regulatory information regarding the use of human/animal participation in research and teaching.
• Demonstrated understanding of the principles of human/animal research protection standards.
• Strong knowledge of grants and contracts function. Significant working knowledge of research procedures and terminology,…