What are the responsibilities and job description for the Quality and Compliance Specialist, IRB position at Tulane University?
Summary
In support of Tulane University’s mission and vision, the IRB Quality and Compliance (SOM) Specialist facilitates the proper conduct of human subjects research for studies conducted through Tulane University School of Medicine. The position requires advanced knowledge of research regulations, guidance, and practice standards as well as the ability to apply this knowledge across a diverse portfolio of research. Responsibilities are divided into two broad categories: 1.) Quality Assurance/Quality Improvement (QA/QI) and 2) Education/Training.
The IRB Quality and Compliance Specialist (SOM)develops and implements training and educational programs for investigators, research staff, and the Institutional Review Board (IRB); serves as an expert resource by providing mentoring and targeted support to investigators, IRB Chairs, members, and staff in the development, implementation, and oversight of research; and performs quality assurance monitoring of research protocol and IRB activities to ensure that the conduct and oversight of human subjects research is in compliance with regulations and in accordance with professional standards. This pro-active approach is intended to minimize risks to human subjects as well as regulatory risks at the investigator and organizational level.
Required Knowledge, Skills, And Abilities
In support of Tulane University’s mission and vision, the IRB Quality and Compliance (SOM) Specialist facilitates the proper conduct of human subjects research for studies conducted through Tulane University School of Medicine. The position requires advanced knowledge of research regulations, guidance, and practice standards as well as the ability to apply this knowledge across a diverse portfolio of research. Responsibilities are divided into two broad categories: 1.) Quality Assurance/Quality Improvement (QA/QI) and 2) Education/Training.
The IRB Quality and Compliance Specialist (SOM)develops and implements training and educational programs for investigators, research staff, and the Institutional Review Board (IRB); serves as an expert resource by providing mentoring and targeted support to investigators, IRB Chairs, members, and staff in the development, implementation, and oversight of research; and performs quality assurance monitoring of research protocol and IRB activities to ensure that the conduct and oversight of human subjects research is in compliance with regulations and in accordance with professional standards. This pro-active approach is intended to minimize risks to human subjects as well as regulatory risks at the investigator and organizational level.
Required Knowledge, Skills, And Abilities
- High-level interpersonal skills
- Ability to analyze data and formulate conclusions
- Ability to simplify complex analysis, tailor presentations and training for a wide variety of audiences including investigators, staff, leadership, and board members
- Acute attention to detail is a necessity as well as the ability to interpret extensive and complex regulations and standards.
- Ability to communicate both verbally and in writing with all levels of the organization.
- Ability to manage and prioritize multiple projects/tasks simultaneously.
- Ability to create verbal and written reports.
- Proficient use of computers; requires solid working knowledge of MS Office Suite (Word, Access, Excel, PowerPoint).
- Experience in an IRB electronic system such as IRB Manager.
- Bachelor's Degree in medical research, scientific, health care related, or regulatory discipline, 3 years’ experience in IRB operations or in the conduct and/or monitoring of research in a clinical or regulatory environment.
- High School Diploma/equivalent and 10 years of directly related work experience.
- Master’s Degree in medical research, scientific, health care related, or regulatory discipline, preferred
- Experience with shared service centers or similar service-oriented structures preferred and preference will be given to those who have demonstrated successful performance in such an environment.
- CCRA, CCRC, CCRP, CHRC, or CIP preferred; required within 1 year of eligibility
