Accounts Receivable Management, Analysis Skills, Auditing, Billing, Cash Flow, Clinical Research, Communication Skills, Customer Satisfaction, Documentation, Federal Laws and Regulations, Health Science, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Identify Issues, Interpersonal Skills, Legal, Maintain Compliance, Microsoft Office, Needs Assessment, Presentation/Verbal Skills, Problem Solving Skills, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Research Skills, Resource Management, Safety Compliance, Scientific Research, State Laws and Regulations, Strategic Planning, Survey Instruments, Time Management, Training Program Development, University/School Regulations, Writing Skills
Market Range: 13
Hiring Range: $5,566.40 - $6,666.67/Monthly
JOB SUMMARY/ESSENTIAL JOB FUNCTIONS:
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.
EDUCATION:
Bachelor's Degree in Business, Education, Law, or a health-related field. (TRANSCRIPT REQUIRED)
EXPERIENCE:
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).
KNOWLEDGE, SKILLS, AND ABILITIES:
- 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.
DUTIES AND 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.
DUTIES AND 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.
U
University of Tennessee System