Regulatory Research Specialist

Job ID: J132326
Company: Allegheny Singer Research Institute
Location: Pittsburgh, PA, United States
Facility: West Penn Hospital
Full/Part Time: Full time
Job Type: Regular
Posted at: Sep 25, 2018

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Description

GENERAL OVERVIEW:

Ensures compliance with federal regulations (FDA, DHHS, and OHRP) throughout the review and approval process of research protocols involving human subjects.

ESSENTIAL RESPONSIBILITIES:

  • Reviews human subject research protocols for conformance with ethical and regulatory standards in compliance with all applicable laws and regulations governing clinical investigations. (20%)
  • Communicates recommendations and approvals to and corresponds with research investigators. Provides technical and analytical support as they relate to and enhance office operations. (10%)
  • Advises investigators regarding federal, state, and local regulations and institutional policies pertaining to human research including recommendations to researchers on human subject protection issues in creating and revising protocols. (20%)
  • Ensures the dissemination of information in review process to the appropriate individuals. Updates, maintains, compiles and prepares database reports. (10%)
  • Primary responsibility for the overall coordination and review of commercial and central IRB applications, including preparation and administration of inter-IRB agreements and individual investigator agreement. (20%)
  • Ensures that IRB meetings are governed by commonly recognized rules of order to facilitate fair and comprehensive discussion of all issues related to research under review. (10%)
  • Participates in continuous improvement of human subject research protection program procedures to assure adequate subject protection and assists with coordination of human subject research review with the biosafety and radiation safety committees. (10%)
  • Performs other duties as assigned or required.

QUALIFICATIONS:

Minimum

  • BA/BS degree in health science or a related field
  • A minimum of 5 years IRB experience
  • At least 2 years experience applying DHHS human subject protection regulations and guidelines; familiarity within research terminology

  • Preferred
  • Certified IRB Professional (CIP)

Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, national origin, sexual orientation/gender identity or any other category protected by applicable federal, state or local law. Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, sexual orientation/gender identity, protected veteran status or disability.
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