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. This position is for the Medical School Campus.
The Compliance Specialist will assist in the development and implementation of the quality assurance and compliance efforts of HRPO. This position will conduct both internal and external quality assurance monitoring. The position will also conduct compliance reviews as part of the compliance review team and serve as the primary staff person responsible for the Protocol Adherence and Review Committee (PARC). The position requires a working knowledge and understanding of complex federal regulations, ethical issues, 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 compliance with WU IRB policies, institutional policies and regulatory requirements
Act as a member of the single IRB team to assess functions of participating sites to ensure compliance with contractual requirements, WU IRB policies and regulatory requirements
Serve as a member of the Compliance Review Team to investigate and review reports of noncompliance, evaluate Corrective Action Preventive Action (CAPA) plans and to ensure compliance with WU IRB policies and regulatory requirements
Serve as primary staff person responsible for the Protocol Adherence Review Committee (IRB) meetings which includes composition of regulatory compliant meeting minutes and serving as the liaison with IRB committee members to address questions or concerns and facilitate resolutions with WU faculty
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
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 research activities such as development of HRPO guidelines, and involvement with HRPO task forces
Special projects as assigned
Bachelor’s Degree required
A minimum of 2 years’ experience conducting human subject research
Certified IRB Professional (CIP) status required when eligible
Experience with quality assurance monitoring
Direct experience working with an Institutional Review Board or other equivalent regulatory review body
Experience developing and/or implementing Corrective Action Preventive Action (CAPA) plans in relation to patient safety and/or research compliance
Comprehension of federal regulations and Institutional policies relating to the conduct of human subject research and able to apply requirements appropriately
General medical knowledge and experience with the conduct of human subjects research
Capable of multi-tasking and prioritizing responsibilities
Able to work under deadline pressures
Excellent analytic, organizational and detail skills
Excellent written and verbal communication skills
Comfortable and able to work within an electronic environment
Working knowledge of Microsoft Office software
Able to function independently in terms of decision-making and meeting job requirements
Cooperative, positive, team-oriented attitude
Easily adapts to changing priorities and processes
The hiring range for this position is $50,294 - $65,374 annually.
-Retirement Savings Plan -22 vacation days -8 Paid Holidays -Sick Time -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 -Other Benefits
Med School HR website (medschoolhr.wustl.edu)
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.
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.