Senior Review Specialist - Human Research Protection Office - 50610

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.

PRIMARY DUTIES AND RESPONSIBILITIES:

1. Manage the review of both biomedical and behavioral research protocols that require specialized regulatory review, transition between expedited and full board teams, or that include novel study design or procedures.
2. Act as expert in both expedited review and full board screening responsibilities. Review biomedical and behavioral research studies for compliance with Federal regulations and Institutional (WUSTL/HRPO) policies and procedures.� Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure, or screen the study for full board review.� Research reviews will include new and continuing review of studies, modifications, etc.
3. Analyze new and current regulations, guidelines, and trends influencing the conduct of human subjects research, and develop and implement forms, standard operating procedures and associated documentation in collaboration with the Managers Expedited and Full Board review teams.
4. Develop and maintain specialized knowledge and/or experience in unique research areas such as anthropology, economics, education, social work, genomics, database, medical device and drug research.� Act as expert consultant to researchers and HRPO staff in these and other specialized areas of research.
5. Develop and generate data reports for Expedited and Full Board Managers to track workflow and consistency of review by HRPO review staff.
6. Act as lead liaison and consultant for HRPO reviewers who are staffing SWAT! office hours and on-call services and with other offices, departments and staff related to special projects as assigned.
7. Act as back up for Team Manager in their absence
8. Serve on team that maintains the Association for the Accreditation of Human Subjects Protections accreditation.
9. Other duties as assigned.

• Bachelor's degree.
• REQUIRED LICENSURE/CERTIFICATION/REGISTRATION:  Certified IRB Professional.

• Three to five years of experience as an IRB expedited reviewer and/or full board analyst.
• Comprehension of and 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.
• General medical knowledge and familiarity with the scientific process.
• Specific knowledge and/or experience in medical and social behavioral research gained by conducting, reviewing IRB submissions.
• Comfortable making independent decisions and acting as consultant for HRPO staff reviewers.
• Detail oriented, including auditing skills.
• Ability to manage several projects at once.
• Conceptual thinking and the ability to apply knowledge to a variety of situations.
• Excellent communication skills, written and oral, including public speaking.
• Cooperative and positive attitude.
• Enjoys working independently and as part of a team.

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.