Research Compliance Specialist Sr.

Job ID: J124781
Company: Allegheny Singer Research Institute
Location: Pittsburgh, PA, United States
Facility: Allegheny General Hospital
Full/Part Time: Full time
Job Type: Regular
Posted at: Jun 6, 2018

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Description

GENERAL OVERVIEW:

Ensures compliance with federal regulations, state laws and institutional guidelines throughout the review and approval process of all research involving human subjects and manages.

ESSENTIAL RESPONSIBILITIES:

  • Manages work flow processes and conducts activities pertaining to IRB review and approval for protocols involving human subjects submitted by researchers; monitors the protocol review process to ensure complete and expedient review of all protocols and ensures all special regulatory issues have been properly addressed and approvals/authorizations obtained. (20%)
  • Provides direction and advice to researchers involving human subject research protocols regarding submission, completeness/accuracy, informed consent documentation, amendments, continuing review protocols and adverse events submission; reviews submitted protocols for exempt or expedited review and approval. (20%)
  • Guides and advises IRB staff, investigators, research teams, hospital administrators and staff regarding regulations and compliance activities as they pertain to clinical research of human subjects; administers Adverse Event Committee and IRB Committee meetings, including minute taking. (20%)
  • Assists with compliance to all federal regulations, institutional policies and procedures, guidelines and state law in IRB files and protocols; assists in the development of policies and procedures. (20%)
  • Assists with the educational sessions with researchers and study coordinators, oversees the management of the IRB database and completes other duties as assigned. (20%)

QUALIFICATIONS:

Minimum

  • Bachelor’s Degree in health or related field
  • Certified IRB Professional (CIP) or Certified IRB Manager (CIM)
  • 5 years IRB or clinical research experience
  • Working knowledge and understanding of scientific and medical concepts
  • Advanced understanding and application of theoretical knowledge of research compliance as it relates to human subject research and IRB functions

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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