Senior Research Compliance Coordinator

The Tulane Human Research Protection Office (HRPO) is the administrative arm of 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 Senior Research Compliance Coordinator is responsible for evaluating IRB protocols and submissions for compliance and consistency with federal regulations, state and/or local laws, sponsored-related requirements, and university policies; handles IRB communications and database management, paper and electronic file management, meeting preparations, post meeting activity, and address day-to-day issues with regards to HRPO and IRB matters. This position will assist the HRPO Director and Assistant Director with overseeing the HRPO staff processing of regulatory activities. This position requires project management skills and the ability to work independently.

The HRPO is a high-profile, high-volume office which requires a self-directed individual who is organized, detailed-oriented, and possesses a high level of interpersonal skills.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree
• Two years of experience and knowledge related to IRB matters and human subjects research protection or equivalent combination of experience and education (typical experience might include ethics, clinical trial performance, industry, and/or experience in an academic health center or medical school);
• Experience with reviewing local and/or state laws and federal regulations (i.e. 45 CFR 46, 21 CFR 50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report), and local IRB policies regarding human subjects research; or ability to learn these regulations;
Experience in Windows-based applications

• Certified IRB professional (CIP) certification is highly desirable or will be required once eligible.

• Knowledge and review of compliance and regulatory components of the informed consent, protocols, and submission process;
• Knowledge of the research submission process
• Knowledge of the regulatory requirements of an informed consent process and documentation of consent provided to research subjects;
• Ability to research, understand, and interpret the Code of Federal Regulations. Working knowledge of the Belmont Report, the Declaration of Helsinki, and the Nuremberg Code;
• Understand the operation of the Food and Drug Administration (FDA) and the Federal Office of Human Research Protections (OHRP);
• Demonstrates administrative skills; and must be motivated and able to work in a high volume office;
• Excellent written and oral communications skills; excellent customer service skills; and must possess a high level of interpersonal skills;
• Highly organized and detail-oriented.