IRB Manager🔍Dean of Research, Stanford, California, United States
📁Compliance Legal📅Jul 13, 2021 Post Date📅90393 Requisition #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.
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:
* - 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:
- 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.
In addition, our preferred requirements include:
- 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, 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 research procedures and terminology, medical terminology, clinical trials, and research data management.
Institutional Review Board professional certification desirable. WORK STANDARDS:
Why Stanford is for You
- 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.
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:
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.
- 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!
- Schedule: Full-time
- Job Code: 4932
- Employee Status: Regular
- Grade: J
- Requisition ID: 90393