Tulane University-posted 4 months ago
New Orleans, LA
Educational Services

The IRB Quality and Compliance Coordinator ensures that research projects meet regulatory and ethical standards by providing professional consultation to researchers and to the Institutional Review Board (IRB) or any other boards that regulate research. An IRB Quality and Compliance Coordinator ensures that researchers comply with regulations, ethical standards, and institutional procedures to protect human subjects through a robust education, training and outreach program, which includes but is not limited to, Post Approval Monitoring responsibilities and initiatives. The targeted audience for the IRB Quality and Compliance Coordinator's training initiatives are research faculty and staff, IRB Members, and HRPO personnel. The position also oversees the review of reportable events and presents to the Institutional Review Board (IRB), as needed. The position provides consultation to researchers and board members on regulatory and procedural compliance, in accordance with the HRPO SOPs. The position develops and delivers compliance training programs to prevent non-compliance during the conduct of research.

  • Provide professional consultation to researchers and the Institutional Review Board (IRB).
  • Ensure compliance with regulations, ethical standards, and institutional procedures.
  • Develop and deliver compliance training programs.
  • Oversee the review of reportable events.
  • Present to the Institutional Review Board (IRB) as needed.
  • Conduct education, training, and outreach programs for research faculty and staff, IRB Members, and HRPO personnel.
  • Bachelor's Degree and three (3) years of human subjects clinical research experience, including legal and/or regulatory research experience.
  • OR High School Diploma/Equivalent with nine (9) years' human subjects clinical research experience, including legal and/or regulatory research experience.
  • Must attain at least one of the following certifications within two (2) years of hire date: IRB Professional Certification (CIP) or Healthcare Research Compliance Certification (CHRC).
  • Juris Doctorate or other advanced degree, or a combination of Bachelor's Degree with three to five years of experience working in human subjects research.
  • Three to five years of experience working under or with regulatory statutes, guidance, policies, and standard operating procedures pertaining to research.
  • Knowledge of the Health Insurance Portability and Accountability Act (HIPAA).
  • Experience with writing policies and standard operating procedures.
  • Public speaking experience.
  • Certified Institutional Review Board (IRB) Professional (CIP) or other certification related to research administration or oversight.
  • Working knowledge of various standard word processing and database software, specifically Microsoft Word, PowerPoint, Access, and other Windows-based applications.
  • Excellent organizational and communication skills.
  • Ability to communicate articulately with researchers, senior administration, regulators, and sponsors.
  • Ability to meet established deadlines and make decisions independently.
  • Ability to assist and provide guidance to co-workers.
  • Highly organized and detail-oriented individual.
  • Ability to work on multiple projects simultaneously and prioritize projects.
  • Ability to maintain confidentiality in all work performed.
  • Ability to work evenings and weekends, as needed.
  • Ability to travel, as needed.
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