Senior Manager, Institutional Review Board
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.
In this position, you will be under the direction of the HRPP Associate Director and the IRB Chair and use 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 also participates in University level meetings on matters that involve the IRB, including noncompliance, writes IRB Policy, and develops educational programs for researchers.
You will also:
- Develop, implement, and manage efficient procedures to facilitate the processing of protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.
- Perform review of complex research protocols, including identifying potential 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.
- Lead special projects or meetings on complex and sensitive 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.
*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
To be successful in this position, you will bring:
- Bachelor's degree and five 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, 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. Knowledge of human/animal subjects and Stanford, federal and state policies and procedures.
- Knowledge of medical/scientific areas, biosafety, health and safety, and epidemiology. Direct IRB or IACUC experience, preferably with an Association for Accreditation of Human Research Participant Protection Programs or Association for Assessment and Accreditation of Laboratory Animal Care accredited institution.
In addition, our preferred requirements include:
- Institutional Review Board professional certification.
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!
- 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
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 for 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.
Consistent with obligations under the law, the University will provide reasonable accommodation to any employee with any disability who requires accommodation to perform the essential functions of his or her job.
Stanford is an equal opportunity 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 another other characteristic protected by law.
- Schedule: Full-time
- Job Code: 4933
- Employee Status: Regular
- Grade: K
- Requisition ID: 88016