Research Integrity Specialist

Job ID: J124639
Company: Allegheny Singer Research Institute
Location: Pittsburgh, PA, United States
Full/Part Time: Full time
Job Type: Regular
Posted at: Jun 18, 2018

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Description

GENERAL OVERVIEW:

Ensures compliance with federal regulations (FDA and NIH) throughout the review and approval process all research protocols involving human subjects.

ESSENTIAL RESPONSIBILITIES:

  • Plans and manages all activities pertaining to the IRB review and approval process of all research protocols involving human subjects submitted by researchers. (20%)
  • Provides direction to researchers regarding protocol submission, correcting medical and technical deficiencies or protocols, informed consent documents, amendments, etc. (20%)
  • Reviews independently protocols submitted by researchers for exempt or expedited review based on clinical expertise/training. (20%)
  • Maintains the IRB database (RAPID). (20%)
  • Maintains compliance with all regulatory agencies, including institutional policy, procedures, guidelines, and federal regulations. (20%)

QUALIFICATIONS:

Minimum

  • BA/BS in Health Sciences of related field
  • 3 years recent IRB or clinical research coordinator experience

Preferred

  • CIM or CRC
  • Certified IRB Professional (CIP)
  • Certified IRB Manager

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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