We are seeking a candidate experienced with regulatory compliance and institutional review boards (IRBs) and that has excellent customer service skills.
In this position, under the direction of the Sr. HRPP 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.
*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.
This is a 100% FTE, benefits-eligible position. For consideration, please submit resume and cover letter. 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.
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, 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.
In addition, our preferred requirements include:
Institutional Review Board professional certification desirable.
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.
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 Research Compliance Office (RCO) is responsible for oversight and management of Stanford University’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 Human Research Protection Program (HRPP) and Administrative Panel Laboratory Animal Care (APLAC) are charged with ensuring that all aspects of the HRPP and APLAC 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 human research.