Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.

This position is full-time and works approximately 40 hours per week. 

This position is in the Human Research Protection Office.  The position is located at the Mid Campus Center.  This position is for the Medical School Campus.

POSITION SUMMARY:

PRIMARY DUTIES AND RESPONSIBILITIES:

1. Conduct quality assurance monitoring under the Human Research Protection Office Quality Assurance Plan to ensure HRPO and WU IRB compliance with WU IRB policies, institutional policies and regulatory requirements.                                                                                                                                                                    
2. Train and develop incoming Expedited Review Specialists and IRB Analysts through new employee monitoring activities covering federal regulations, guidance governing the use of human subjects, responsible conduct of research and HPRO policies and procedures.  Follow-up with the appropriate manager to assess, evaluate and modify training as needed to ensure successful completion.
3. Serve as a resource for faculty and staff regarding interpretation of federal regulations governing human subject research, along with policies, procedures and practices pertaining to human studies.
4. Identify workflow processes for inefficiencies and develop strategies for improvement.
5. Develop and update of policies, procedures and guidance documents as needed.
6. Perform other quality assurance monitoring functions as needed and ad hoc document preparation related to external requests of IRB records from government agencies, funding entities, accrediting agencies or as part of subpoenas for legal proceedings.
7. Serve on team which maintains the Association for the Accreditation of Human Subjects Protections accreditation. Lead HRPO projects associated with maintaining this institutional accreditation.

1. Provide back-up and support for co-workers on an as needed basis.
2. Participate in continuing education in the field of human subject research.
3. Attend conferences or other educational meetings as appropriate.
4. Contribute to IRB-related activities such as development of HRPO guidelines, and involvement with HRPO task forces.
5. Special projects as assigned.

• Bachelor’s degree.
• Experience with quality assurance monitoring.
• Three to five years of relevant experience in administration of IRB and/or clinical trials or research administration.
• Successful applicant will be expected to obtain CIP upon meeting eligibility requirements.

• Master’s degree.
• Direct experience working with an Institutional Review Board.
• Demonstrated detailed knowledge of federal, state, local regulations and in-depth understanding of ethical principles regarding the conduct of research and regulatory issues involving protection of human subjects in research.
• Ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45CFR46, 21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report, and the HRPO Policies and procedures.
• Ability to manage multiple projects at once with a high level of accuracy and attention to detail.
• Critical review and auditing skills.
• Ability to work independently to meet stated objectives with minimal supervision.
• Demonstrate excellent interpersonal, analytic and leadership skills.
• Knowledge of the scientific research process in both biomedical and behavioral fields.
• Strong conceptual and critical thinking skills with the ability to apply knowledge to a variety of situations.
• Ability to exercise creativity in solving problems effectively while employing good judgment.
• Excellent communication skills, written and oral, including public speaking.
• Cooperative and positive attitude including demonstrated team building skills.
• Accepts and adapts to changes in office procedures or priorities.
• Skilled in working in an all-electronic environment including expertise with Microsoft Office.
• Experience developing and/or implementing Corrective Action Preventive Action (CAPA) plans in relation to patient safety, research compliance, and quality assurance monitoring.

The hiring range for this position is $56,472 - $73,403 annually.

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

This position is eligible for full-time benefits.  Please click the following link to view a summary of benefits:  https://wustl.box.com/s/8wkhs25yssf0775x9d6nd6vqa7obpth7.

This position is grade G12.

Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account.  If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor.  To attach these documents, go to:  My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.