Senior Institutional Review Board (IRB) Manager
Dean of Research, Stanford, California, United States

Schedule: Full-time
Job Code: 4103
Employee Status: Regular
Grade: F
Requisition ID: 94411

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 help assure that 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 bio-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, you will be under the direction of the HRPP Associate Director and IRB Chair, you will conduct in-depth protocol review using advanced regulatory knowledge and experience. Your primary responsibility will be to manage the protocol review process, identify issues, and independently determine whether the components of the proposed research are in compliance with federal, state and local regulations, Stanford University policies, and accreditation standards. This position collaborates with University offices on matters that involve the IRB, including, but not limited to, Institutional and Financial Conflicts of Interest, Office of Technology Licensing (OTL), Office of Sponsored Research (OSR), and Privacy. This position will also propose IRB Policy and develop educational programs for researchers. This position supervises a full-time IRB Manager position.

Please note that 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

This is a 100% FTE, benefits-eligible position. For consideration, please submit resume. All final candidates must complete a background check.

This position has the potential to be a hybrid work role - a combination of onsite work and telecommuting - based on business and operational need.

CORE DUTIES:

• 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/IACUC 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.
• Manage the work of other employees, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring, as assigned.

MINIMUM REQUIREMENTS:

Education & Experience:

Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.

Knowledge, Skills, and Abilities:

• 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 contract's 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 strong verbal and written communication skills.
• Advanced knowledge of human subjects/animal protection regulations and best practices, as evidenced by certification (e.g., Certified IRB Professional, Certified Professional IACUC Association).
• Knowledge of medical/scientific areas, such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, and epidemiology.
• Direct IRB or IACUC experience, preferably with an Association for Accreditation of Human Research Participant

In addition, our preferred requirements include:

• Institutional Review Board professional certification.

Certifications and Licenses:

Ability to obtain or retain Institutional Review Board or Institutional Animal Care and Use Committee professional certification.

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.

WORKING CONDITIONS:

• May work extended or non-standard hours based on project or business needs. Occasional cross campus and local travel may be required. May be exposed to allergens, biohazards, chemicals, radiation or electromagnetic fields.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

Why Stanford is for You

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.


To be considered for this position please visit our web site and apply on line at the following link: https://apptrkr.com/3064593

Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.







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