| EOE Statement:|
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.
Department Name/Job Location:
This position is in the Department of Human Research Protection Office (HRPO). The position is located at 22 North Euclid. This position is for the Medical School Campus.
This position is an IRB committee member designated to conduct and approve expedited review of biomedical and behavioral research involving human participants. Like review by the convened IRB, expedited review must fulfill all the requirements of review according to applicable HHS and FDA regulations.
PRIMARY DUTIES AND RESPONSIBILITES:
- 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. Research reviews will include new and continuing review of studies, modifications, etc.
- Provide justification for expedited classification or refer the submission to the full board committee if expedited classification is found not to be appropriate.
- Communicate with investigators (via telephone, myIRB and in person) 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.
- Maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.
- Provide guidance to research coordinators and investigators regarding applications in preparation for submission to HRPO, via myIRB, SWAT on call and office hours.
- Consult 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, HRPO colleagues and scientists in the social-behavioral-educational sciences, HRPO and Institutional colleagues in research administration, and federal officials.
- Serve as a primary reviewer and voting member of a convened IRB.
- Serve as a resource for other IRB members.
- Perform educational presentations (formal and informal) to HRPO colleagues, to WU research community, and at national meetings of IRB professionals.
- Participate in special projects, development of guidance documents, and/or quality assurance/improvement assessments.
- Other duties as assigned.
The hiring range for this position is commensurate with education and experience.
Bachelor’s degree is required and 3 –5 years experience in clinical research and/or IRB experience preferred. Must have working knowledge of the federal regulations governing research, including the new HIPAA regulations.
- Master’s degree preferred.
- Successful applicant will be expected to obtain CIP upon meeting eligibility requirements.
CRITICAL SKILLS/EXPERTISE NEEDED:
- 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.
- Comfortable making independent decisions within a designated framework.
- 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 skills¾written and oral, including public speaking.
- Cooperative and positive attitude.
- Enjoys working independently and as part of a team.
- Accepts and adapts to changes in office procedures or priorities.
- Experience with Microsoft Office Professional software (Word, Access, Excel, Power-Point, Outlook).
- Clinical research coordinator and/or human research regulatory coordinator experience. IRB experience preferred.
- Ideal candidate profile: clinical research coordinator with a working knowledge of the federal regulations governing research, including the HIPAA regulations.
This position is full-time and works approximately 40 hours per week.
Internal Applicant Instruction:
This position is grade G11.
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.
-Retirement Savings Plan
-22 vacation days
-8 Paid Holidays
-Tuition benefits for employee, spouse and dependent children
-Free Metro Link/ Bus pass
-Free Life Insurance
-Health, Dental, Vision
-Health Savings Accounts (HSA)
-Long Term Disability Insurance
-Flex Spending Plan
Med School HR website (medschoolhr.wustl.edu)