Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
The Tulane Human Research Protection Office (HRPO) administers the University's Human Research Protection Program (HRPP) and Institutional Review Boards (IRBs), which are charged with reviewing and monitoring human subjects' research under the auspices of the University. The employee in this position participates in all aspects of IRB communication and database management, paper and electronic file management, meeting preparation and post meeting activities. The employee supports the research community with IRB protocol submissions and the use of IRB forms.
Required Knowledge, Skills, and Abilities
Knowledge of current FDA, OHRP regulations for clinical research and related to IRB; or ability to learn these regulations
Ability to demonstrate administrative skills
Ability to be motivated and able to work in a high volume office
Excellent written and oral communication skills
Excellent customer service skills
Knowledge of Windows-based applications
Ability to be highly organized and detailed-oriented
High level of interpersonal skills
Project management skills
Ability to work independently
Required Education and/or Experience
Bachelor's degree and two years of experience related to IRB issues and human subjects research protection, ethics, clinical trial performance, industry, and/or experience in a clinical field/setting
OR
High School or equivalent with 6 years of related experience
Preferred Qualifications
Certified IRB Professional (CIP certification is highly desirable or will be required once eligible)
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