Regulatory Compliance Specialist

Tulane University-posted 3 months ago
Entry Level
New Orleans, LA
Educational Services
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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.

  • Participate in all aspects of IRB communication and database management.
  • Manage paper and electronic file management.
  • Prepare for meetings and handle post-meeting activities.
  • Support the research community with IRB protocol submissions and the use of IRB forms.
  • 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 detail-oriented.
  • High level of interpersonal skills.
  • Project management skills.
  • Ability to work independently.
  • 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.
  • Certified IRB Professional (CIP certification is highly desirable or will be required once eligible).
  • CIP certification is highly desirable or will be required once eligible.
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