Research Compliance Specialist

Job ID: J136951
Company: Allegheny Singer Research Institute
Location: Pittsburgh, PA, United States
Facility: 4 Allegheny Center
Full/Part Time: Full time
Job Type: Regular
Posted at: Dec 6, 2018

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Description

GENERAL OVERVIEW:

Works to ensure departmental compliance with federal regulations, state laws and institutional guidelines throughout the review and approval process of all research involving human subjects.

ESSENTIAL RESPONSIBILITIES:

  • Manages departmental work flow processes and activities pertaining to IRB submission, review and approval of protocols involving human subjects submitted by researchers; monitors the protocol review process to ensure complete and expedient review while ensuring any special regulatory issues have been properly addressed and any required approvals/authorizations obtained.
  • Provides direction and advice to researchers involving human subject research protocols including submission, completeness/accuracy, informed consent documentation, amendments, continuing review protocols and adverse events submission; reviews submitted protocols for exempt or expedited review and approval.
  • Guides and advises departmental investigators, research teams, hospital administrators and staff regarding regulations and compliance activities as they pertain to clinical research of human subjects; supports Adverse Event Committee and IRB Committee meetings, as needed.
  • Works with the IRB staff to facilitate throughput of studies through the review process; conveys department study priorities to the IRB Committees.
  • Assists with compliance with all federal regulations, institutional policies and procedures, guidelines and state law in IRB files and protocols; assists in the development of departmental procedures.
  • Conducts and supports educational sessions with researchers and study coordinators.
  • Performs other duties as assigned or required.

QUALIFICATIONS:

Minimum

  • Bachelor’s Degree in health or related field
  • 4 years IRB or clinical research experience
  • Advanced understanding and application of theoretical knowledge of research compliance as it relates to human subject research and IRB functions

Preferred

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

Compliance Requirement: As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times.  In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy.  
 
Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements. 
 

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.
EEO is The Law
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For accommodation requests, please call HR Services at 844-242-HR4U or visit HR Services Online at HRServices@highmarkhealth.org

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