Expedited Review Specialist (Remote) - Human Resource Protection Office Reserve

Scheduled Hours
40

Position Summary
The Expedited Review Specialist reviews all research involving human subjects conducted by WashU faculty/staff/students and all research conducted at any WashU affiliated institution. This role is an IRB committee member designated to conduct and approve expedited review of biomedical and behavioral research involving human participants.

Job Description

Primary Duties & Responsibilities:

• Reviews biomedical and behavioral research studies for compliance with Federal regulations and Institutional (WUSTL/IRB) policies and procedures. Identifies issues or concerns that must be addressed in order to approve the research under the expedited procedure. Research reviews will include new studies, modifications to currently approved research, and continuing reviews.

• Provides justification for expedited classification or refer the submission to the full board committee if expedited classification is found not to be appropriate.

• Communicates with investigators to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any. Contingencies (requests for changes or clarifications) should include standard statements from myIRB manual, regulatory guidance and education as applicable. Communications must be clear, concise and grammatically correct.

• Maintains a working knowledge of current regulations, guidelines and trends influencing the conduct of human subject research.

• Provides guidance to research coordinators and investigators that are preparing IRB applications.

• Provides help services to include an on-call phone line service and Office Hours. Consults with other experts as needed to conduct informed, qualitative review of biomedical and behavioral research involving human participants. Experts may include physician-scientists or other clinical professionals, scientists in the social-behavioral-educational sciences, and institutional colleagues in research administration.

• Serves as a primary reviewer and voting member of a convened IRB.

• Serves as a resource for other IRB members. Performs educational presentations (formal and informal) to HRPO colleagues, to WU research community and at national meetings of IRB professionals.

• Participates in special projects, development of guidance documents and/or quality assurance/improvement assessments.

• Other duties as assigned.

Working Conditions:

Job Location/Working Conditions:

• Normal office environment.

Physical Effort:

• Typically sitting at a desk or a table.

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:

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

Certifications/Professional Licenses:

No specific certification/professional license 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:

Master's degree

Certifications/Professional Licenses:

Certified IRB Professional - CIP Council

Work Experience:

Human Subject Research (1 Year), Healthcare (1 Year), Institutional Review Board (Irb), Clinical Trials, Or Healthcare (1 Year), Clinical Trials (1 Year)

Skills:

Adaptability, Business Process Auditing, Clinical Research Coordination, Clinical Trials, Code of Federal Regulations, Detail-Oriented, Health Care, HIPAA Regulations, Human Subjects Protections, Human Subjects Research, Independent Decision-Making, Institutional Review Board (IRB), Medical Knowledge, Microsoft Office, Multitasking, Oral Communications, Public Speaking, Research Compliance, Scientific Research, Written Communication

Grade
G11

Salary Range
$53,100.00 - $90,600.00 / Annually

The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Questions

For frequently asked questions about the application process, please refer to our External Applicant FAQ .

Accommodation

If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu  or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an 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.

Benefits Statement

Personal

• Up to 22 days of vacation, 10 recognized holidays, and sick time.

• Competitive health insurance packages with priority appointments and lower copays/coinsurance.

• Take advantage of our free Metro transit U-Pass for eligible employees.

• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.

Wellness

• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Family

• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.

• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/

EEO Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, citizenship (where prohibited by federal law), age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.