IRB Review Analyst (Remote) - Human Research Protection Office

Scheduled Hours 40 Position Summary The IRB Review Analyst will attend committee meetings to document the committee’s meeting actions, deliberations on regulatory and ethical issues and changes to the research plan determined by the committee to be necessary to secure approval. This role will communicate the committee’s requirements to the research team and work with the research team in resolving any required actions.

Job Description

Primary Duties & Responsibilities:

• Screen research studies for compliance with federal regulations (including HIPAA compliance) and institutional policies and procedures. Identify issues or concerns that must be addressed in order for the committee to review and approve the research. Screening activities encompass new submissions, continuing review of studies, amendments and unanticipated problems.
• Serve as a liaison between the committee members and research team. When necessary, contact investigators or coordinators to obtain additional information or clarification prior to the committee meeting.
• Attend committee meetings and serve as a resource on human subject research regulations and institutional requirements for committee members and Chairs.
• Compose meeting minutes that are in compliance with federal regulations and incorporate complex scientific and regulatory language, in addition to relevant ethical concerns. Letters must be clear, concise and grammatically correct.
• Counsel research faculty and support staff in resolving committee contingencies. Once submitted, review responses from investigators and approve protocols (when compliant).
• Distribute minutes for approval by committee members.
• Provide educational and directive responses to general human subject questions from WU investigators and research staff.
• Provide guidance to WU Investigators and research staff regarding applications in preparation for submission to HRPO.
• Maintain a working knowledge of current regulations, guidelines and trends influencing the conduct of human subject research.
• Serve as a member of the SWAT! Team (Staff with Answers Today). SWAT! is a resource that provides an on-call service and office hours to assist investigators, research staff and students with questions about any issue related to IRB review.
• Provide back-up and support for coworkers on an as needed basis.
• Participate in continuing education in the field of human subject research. Opportunities to attend a national conference are also available.
• Perform other duties as assigned.

Working Conditions: Job Location/Working Conditions:

• Normal office environment.

Physical Effort:

• Typically sitting at desk or table.
• Typically standing or walking.
• Occasional lifting (25 lbs. or less).

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. Education:

Required Qualifications

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: Relevant Experience (1 Year) Skills: Not Applicable Driver's License: A driver's license is not required for this position. Required Qualifications: More About This Job

• Certified IRB Professional (CIP) status required when eligible.

Education:

Preferred Qualifications

Master's degree Certifications/Professional Licenses: Certified IRB Professional - CIP Council Work Experience: Clinical Research (1 Year) Skills: Cooperation, Customer Service, Deadline Management, Decision Making, Detail-Oriented, Good Clinical Practice (GCP), Health Insurance Portability & Accountability Act (HIPAA), Human Subjects Protections, Institutional Review Board (IRB), Medical Knowledge, Multitasking, Oral Communications, Organizing, Paperless Environments, Positive Thinking, Prioritization, Problem Solving Tools, Regulatory Research, Research Coordination, Researching, Software Applications, Stress Management, Teamwork, Working Independently, Written Communication Grade G10 Salary Range $49,700.00 - $82,100.00 / 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 [email protected] 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 and especially encourages applications by those from underrepresented groups. 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, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply. Apply tot his job Apply To this Job