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IND/IDE Regulatory Coordinator

Company: UNC-Chapel Hill
Location: Chapel Hill
Posted on: September 19, 2022

Job Description:

Position Summary

The IND / IDE Regulatory Coordinator will assist with tracking and supporting regulatory compliance of UNC investigators who hold or are submitting investigational new drug applications ( IND ) or investigational device exemption ( IDE ) requests to the FDA . The Regulatory Coordinator will also field questions from investigators related to regulatory compliance in clinical trials, and specifically about UNC's IND and IDE policies and answer or direct them appropriately.

This position may be eligible for hybrid or remote work.

Minimum Education and Experience Requirements

Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Required Qualifications, Competencies, and Experience

The selected candidate must demonstrate the following:
* Familiarity with US federal regulations related to clinical research studies, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ) guidelines, and Good Clinical Practice ( GCP )
* Ability to work both independently and as part of a team
* Proficiency with Microsoft Word, Excel, Outlook, and SharePoint

Preferred Qualifications, Competencies, and Experience

* Working knowledge of clinical trial management systems ( CTMS ), especially Advarra OnCore
* 1+ years experience in clinical research involving human subjects
* SOCRA CCRP or ACRP CCRC / CCRA certification
* Experience with IND / IDE applications

Required Licenses/Certifications

Special Physical/Mental Requirements

Campus Security Authority Responsibilities

Not Applicable.

Position/Schedule Requirements

Keywords: UNC-Chapel Hill, Chapel Hill , IND/IDE Regulatory Coordinator, Other , Chapel Hill, North Carolina

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