Regulatory Compliance Specialist jobs in United States
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Tulane University · 5 months ago

Regulatory Compliance Specialist

Tulane University is seeking a Regulatory Compliance Specialist to support its Human Research Protection Office (HRPO) and Institutional Review Boards (IRBs). The role involves participating in IRB communication, database management, and assisting the research community with protocol submissions and IRB forms.

EducationHealth CareHigher EducationUniversities

Responsibilities

Participates in all aspects of IRB communication and database management, paper and electronic file management, meeting preparation and post meeting activities
Supports the research community with IRB protocol submissions and the use of IRB forms

Qualification

FDA regulationsOHRP regulationsIRB knowledgeCustomer serviceWindows applicationsProject managementAdministrative skillsWritten communicationOral communicationInterpersonal skillsOrganizational skillsIndependent workDetail-orientedMotivation

Required

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
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

Certified IRB Professional (CIP certification is highly desirable or will be required once eligible)

Company

Tulane University

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A member of the prestigious Association of American Universities, Tulane University is consistently ranked among the top 50 universities in the nation.

Funding

Current Stage
Late Stage
Total Funding
$14M
Key Investors
National Institute on Aging
2022-03-04Grant· $14M

Leadership Team

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Janaki Sundaresan
Co-Founder of Health Equity Fellowship
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Lekh Parekh
Co-founder and Vice President of Tulane Table Tennis Club
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