Senior Manager, Institutional Review Board
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 Sr. IRB Manager position. Stanford University's IRB panel 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 subject to complex federal. Familiarity with medical and gene transfer research is preferred.
Under the direction of the HRPP Assistant Director and the IRB Chair, the Sr. IRB Manager conducts in-depth protocol review using advanced regulatory knowledge and experience. The primary responsibility is to manage the protocol review process and to independently determine whether the components of the proposed research comply with federal, state and local regulations, Stanford University policies, and accreditation standards. This position also interacts with the Administrative Panel on Biosafety (APB) for gene transfer reviews and attends the monthly APB meetings.
Note: Not all unique aspects of the job are covered by this job description
- Develop, implement, and manage efficient procedures to facilitate the processing of medical and gene transfer 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 (e.g., gene transfer, HIV AIDS protocols, stem cells, clinical trials, research with vulnerable populations, transgenic, or neurosciences).
- Manage the work of other employees, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring, as assigned.
* Other duties may also be assigned
*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 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.
- Advanced knowledge of human subjects/animal protections 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 Protection Programs or Association for Assessment and Accreditation of Laboratory Animal Care accredited institution.
*Certifications and Licenses:*
Ability to obtain or retain Institutional Review Board or Institutional Animal Care and Use Committee professional certification.
- 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.
- 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.
- 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 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.
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 his or her job.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.
- Schedule: Full-time
- Job Code: 4933
- Employee Status: Regular
- Grade: K
- Requisition ID: 86663