Tulane University
Regulatory Compliance Specialist
Tulane University, New Orleans, Louisiana, United States, 70123
Overview
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. Responsibilities Participate in all aspects of IRB communication and database management, paper and electronic file management, meeting preparation and post meeting activities. Support 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 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)
Seniority level
Entry level
Employment type
Full-time
Job function
Legal
Industries
Higher Education
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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. Responsibilities Participate in all aspects of IRB communication and database management, paper and electronic file management, meeting preparation and post meeting activities. Support 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 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)
Seniority level
Entry level
Employment type
Full-time
Job function
Legal
Industries
Higher Education
#J-18808-Ljbffr