What are the responsibilities and job description for the Regulatory Compliance Specialist position at Tulane University?
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 regulationsAbility 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)
