Washington University of St. Louis Human Research Protection Office in St. Louis, Missouri

Job Type/Schedule

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.

Essential Functions

POSITION SUMMARY:

Provides leadership for designated areas of the Human Research Protection Office (HRPO) and Institutional Review Board (IRB) and works collaboratively with the Executive Director to assure compliance with federal regulations, state laws, accreditation requirements and institutional policies. Key responsibilities include data analytics, education, management of designated staff, and ongoing review and revision of policies and procedures.

PRIMARY DUTIES AND RESPONSIBILITIES:

  1. Responsible for revising and developing policies, procedures and guidances related to human subjects protections.
  2. Develop and oversee HRPO data analytics with regard to workflow processes, education and support activities (e.g. HRPO SWAT! and HRPO Study Initiation Program), and IRB operations including member evaluations and membership efforts. Identify and assess key data for monitoring and improving the activities of HRPO and the IRB. Design and implement surveys or other tools to provide continuous feedback from the research community.
  3. Supervise review, education, or operational personnel. Supervise training and provide continuing education to assure compliance with applicable regulations, laws, guidelines, policies, and procedures. Interview and hire for vacant positions, maintain position descriptions, meet regularly with direct reports to provide feedback, establish goals, assess performance, and counsel as appropriate. Prepare performance evaluations, disciplinary actions; leave records and recommendations for salary increases as appropriate.
  4. Oversee integration of processes and procedures for consistency and effectiveness between the HRPO review teams. Collaborate with HRPO leadership to maintain written policies and procedures in support of effective and efficient workflow and review activities.
  5. Act as a resource and point of contact for staff, IRB members, and the research community with regard to study design and conduct and IRB submission and review processes.
  6. Act as the administrative and regulatory representative at IRB meetings. Provide support and expertise to IRB Chairs in assessment of regulatory applicability and compliance with IRB policies and procedures.
  7. Oversee and conduct HRPO and IRB internal quality assurance and quality improvement activities.
  8. Other duties as assigned.

Required Qualifications

  • Master’s level degree required or bachelor’s degree with comparable research and management experience.
  • 5 years of experience in human subject research, research administration and/or regulatory compliance.
  • Experience in human subjects research education and compliance.
  • Demonstrated experience and success in progressive levels of management required.
  • Strong customer service, communication and organizational skills.
  • Ability to multi-task with a strong attention to details and accuracy.
  • Flexibility and ability to adapt to a changing environment.
  • Efficient in Microsoft Word, Excel, and PowerPoint.
  • Professional demeanor and ability to work independently.
  • Certified IRB Professional (CIP) status required when eligible.

Preferred Qualifications

  • Direct IRB experience in a management or leadership role
  • Efficient in an IRB-specific software system
  • Experience in an AAHRPP-accredited University Human Research Protection Program compliance unit
  • Excellent communication and customer service skills both written and verbal
  • Must have the capacity to communicate effectively with a variety of customers including faculty, research coordinators, institutional officials, and departmental staff
  • Demonstrated management and supervision, leadership, and administrative capabilities
  • Medical knowledge and experience with the conduct of clinical research
  • Analytic skills and ability to problem solve within the framework of major federal regulatory requirements, state laws, accreditation standards, and institutional policies and procedures
  • Experience with federal regulations and standards including Human Subject Protections, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report
  • Strong independent decision making
  • Conceptual thinking and problem solving as well as the ability to apply knowledge to a variety of situations
  • Ability to manage several projects at once
  • Demonstrated organizational skills
  • Cooperative and positive attitude to contribute to the team

Salary Range

The hiring range for this position is $77,314 - $102,440 annually.

Benefits

  • 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)

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.

Job Title: Associate Director - Human Research Protection Office - 41940

Job ID: 41940

Location: Medical School

Full/Part Time: Full-Time

Regular/Temporary: Regular