IRB Coordination Manager (Research Compliance Manager 1)

BUSINESS TITLE:

IRB Coordination Manager (Research Compliance Manager 1)

WORK SCHEDULE:

This position is a hybrid work role – a combination of onsite work and telecommuting – based on business and operational need.

BUDGETED SALARY: $99,448 - $140,000

SCHOOL/UNIT DESCRIPTION:

The Human and Animal Research Compliance (HARC) office 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 HARC 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.

POSITION SUMMARY:

In this position, under the direction of the 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 for Continuing Reviews (renewals) and Modifications to 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. 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. All final candidates must complete a background check.

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.

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.

Minimum Education and Experience

Bachelor’s degree and three 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.

• 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.

Certificates and Licenses Required

Institutional Review Board or Institutional Animal Care and Use Committee professional certification desirable.