IRB Compliance Advisor-Institutional Review Board

University of Tennessee•Memphis, TN

About The Position

The Institutional Review Board (IRB) Compliance Advisor manages highly complex duties to assist the investigator in complying with relevant federal regulations, state laws, and institutional policies related to the conduct of clinical research and in properly documenting compliance with those requirements. The components of this role are: (1) reviewing of IRB records to verify compliance with federal, state, and university regulations, (2) managing departments accounts receivables, (3) developing customer satisfaction and needs assessment instruments and analyzing the results to identify educational need so the university’s researchers and client institutions regarding regulatory requirements and navigation of IRB application forms and processes, and (4) developing and implementing training programs and materials to meet identified educational needs. Audits and other activities may be conducted at UT Health Science Center and at each of the affiliated institutions.

Requirements

Bachelor’s Degree in Business, Education, Law, or a health-related field. (TRANSCRIPT REQUIRED)
Two (2) years of professional or business experience (research compliance experience preferred); OR Master’s Degree in lieu of experience (Research compliance experience preferred).
Experience with federal regulations for the protection of human subjects preferred.
Ability to prepare for and conduct audits or quality assurance.
Ability to write detailed reports.
Ability to develop customer satisfaction instruments and analyze results.
Ability to identify educational needs and develop strategies for meeting those needs.
Ability to analyze and apply ethical codes.
Critical problem solving, analytical, resource management, and creative thinking skills.
Ability to work independently.
Skilled in the use of the computer, including Microsoft Office and SurveyMonkey or other survey instruments.
Excellent interpersonal, verbal, and written communication skills.

Responsibilities

Identifies IRB submissions to be audited through the review of ongoing studies.
Systematically reviews IRB records to ensure regulatory compliance and ethical safety.
Manages the department’s incoming cash flow by generating, sending, and tracking IRB review invoices to ensure timely payments.
Investigates and solves discrepancies between IRB review payments and invoiced amounts.
Develops and prepares audit reports and conducts appropriate follow-up to ensure that deficiencies are corrected timely.
Develops, administers, and analyzes the results of customer satisfaction and needs assessment instruments.
Identifies educational needs of researchers based on results of survey instruments and develops strategies and training programs for meeting those needs.
Creates study packets for new investigator-initiated studies to increase education and compliance.
Develops and presents topics for quarterly IRB training sessions and IRB Insights.
Completes comprehensive reviews of extremely complicated scientific research proposals and accompanying documents, and identifies regulatory issues as well as institutional policy issues, and makes recommendations.
Performs other duties as assigned.