Scheduled Hours

40

Position Summary

This position will develop and implement an education and compliance program for the Human Research Protection Office and the Washington University IRB (WU IRB) system. This will include, but may not be limited to, development of an education plan, development and implementation of training programs, development of material for education and compliance purposes, compliance activities including investigations and monitoring and overall quality improvement assessment of the education and compliance program. This position will include developing programs and monitoring for research sites external to Washington University that the WU IRB provides oversight for as an IRB.

Job Description

Primary Duties & Responsibilities:

• Develops, implements, evaluates and maintains an education plan for researchers and their staff covering federal regulations, Washington University policies and procedures, and guidance governing the conduct of human subjects' research.
• Develops, implements and evaluates a plan to ensure internal and external compliance with federal regulations, state law, and Washington University policies and procedures.
• Serves as a resource for faculty and staff regarding procedures and practices pertaining to the conduct of human subject research.
• Coordinates and evaluates HRPO programs such as the HRPO SWAT! and Study Initiation Program as needed.
• Develops, implements and delivers educational initiatives both as part of the overall education plan and in response to corrective actions required from findings of non-compliance.
• Monitors human subject research protocols both for measures of overall compliance, to investigate allegations of non-compliance, and in response to corrective action plans required by the IRB.
• Analyzes IRB submissions to determine the needs of the research community and to measure program success.
• Maintains IRB policies and procedures and other guideline materials to ensure that they are compliant with federal regulations and institutional policies.
• Collaborates with other compliance offices to understand and integrate the concepts of ethical conduct of research.
• Maintains an excellent working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.
• Contributes to IRB-related research activities such as development of guidelines, training materials, writing articles, grant work or poster presentations.
• Serves as a resource to the research community, HRPO staff, and IRB committee members for issues related to IRB review and human subject research.
• Serves as an Administrative Representative for the IRB and member of the IRB as needed.
• Participates in continuing education in the field of human subject research as demonstrated by attendance at local events (e.g., IRB consortium meetings and HRPO Question and Answer sessions) and national conferences as appropriate.
• Executes special projects as assigned.
• Performs other duties as assigned.

Working Conditions:
Job Location/Working Conditions

• Normal office environment.

Physical Effort

• Typically sitting at desk or table.

• Typically standing or walking.

• Repetitive wrist, hand, or finger movement.

Equipment

• Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

Master’s degree or combination of education and/or experience may substitute for minimum education.

Certifications:

No specific certification is required for this position.

Work Experience:

No specific work experience is required for this position.

Skills:

Not Applicable

Driver's License:

A driver's license is not required for this position.

More About This Job

Certified IRB Professional (CIP) status required when eligible.

Preferred Qualifications

Education:

Ph.D. - Doctor of Philosophy

Certifications:

Certified IRB Professional - CIP Council

Work Experience:

Relevant Experience (3 Years)

Skills:

Clinical Trials, Educational Materials Development, Health Care, Instit