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.
Department Name/Job Location:
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.
The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) regulations mandate that institutions receiving federal research funds maintain an Institutional Review Board (IRB) to review all human subject research proposals so as to “protect the rights and welfare of human subjects.” The Washington University IRB reviews all research involving human subjects conducted by WU faculty/staff and all research conducted at any WU affiliated institution. The Human Research Protection Office is tasked with supporting the IRB’s mission to protect the rights and welfare of research participants.
The Quality Assurance Specialist will collaborate with HRPO leadership in the development and implementation of HRPO’s internal quality improvement and assurance program. The Quality Assurance Specialist will conduct reviews as required by the office’s internal QA/QI program to ensure compliance with federal regulations, institutional policies, and other agency requirements governing human subject research
PRIMARY DUTIES AND RESPONSIBILITIES:
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.
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.
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.
Identify workflow processes for inefficiencies and develop strategies for improvement.
Develop and update of policies, procedures and guidance documents as needed.
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.
Serve on team which maintains the Association for the Accreditation of Human Subjects Protections accreditation. Lead HRPO projects associated with maintaining this institutional accreditation.
Provide back-up and support for co-workers on an as needed basis.
Participate in continuing education in the field of human subject research.
Attend conferences or other educational meetings as appropriate.
Contribute to IRB-related activities such as development of HRPO guidelines, and involvement with HRPO task forces.
Special projects as assigned.
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.
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.
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.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.