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Tulane University · 1 month ago

Quality and Compliance Specialist, IRB

New Orleans, LA

Full-time

Onsite

Mid Level

3+ years exp

Tulane University is committed to supporting human subjects research through its IRB Quality and Compliance Specialist role. This position involves ensuring compliance with research regulations and providing training and support to research staff and investigators.

EducationHigher EducationMedical

Responsibilities

Develops and implements training and educational programs for investigators, research staff, and the Institutional Review Board (IRB)

Serves as an expert resource by providing mentoring and targeted support to investigators, IRB Chairs, members, and staff in the development, implementation, and oversight of research

Performs quality assurance monitoring of research protocol and IRB activities to ensure that the conduct and oversight of human subjects research is in compliance with regulations and in accordance with professional standards

Qualification

IRB operations experienceData analysisMS Office SuiteTraining program developmentVerbalAttention to detailWritten communicationProject managementReport creationIRB electronic systemsMaster's Degree preferredCertification CCRACertification CCRCCertification etc.Interpersonal skills

Required

High-level interpersonal skills

Ability to analyze data and formulate conclusions

Ability to simplify complex analysis, tailor presentations and training for a wide variety of audiences including investigators, staff, leadership, and board members

Acute attention to detail is a necessity as well as the ability to interpret extensive and complex regulations and standards

Ability to communicate both verbally and in writing with all levels of the organization

Ability to manage and prioritize multiple projects/tasks simultaneously

Ability to create verbal and written reports

Proficient use of computers; requires solid working knowledge of MS Office Suite (Word, Access, Excel, PowerPoint)

Experience in an IRB electronic system such as IRB Manager

Bachelor's Degree in medical research, scientific, health care related, or regulatory discipline, 3 years' experience in IRB operations or in the conduct and/or monitoring of research in a clinical or regulatory environment

High School Diploma/equivalent and 10 years of directly related work experience

Preferred

Master's Degree in medical research, scientific, health care related, or regulatory discipline, preferred

Experience with shared service centers or similar service-oriented structures preferred and preference will be given to those who have demonstrated successful performance in such an environment

CCRA, CCRC, CCRP, CHRC, or CIP preferred; required within 1 year of eligibility

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.

Founded in 1834

New Orleans, Louisiana, USA

1001-5000 employees