IRB Program Specialist

St. Joseph Hospital & Medical Center • Phoenix, AZ

4d

About The Position

Oversees the day-to-day operations of the Institutional Review Board (IRB) in accordance with all applicable institutional, state, federal and other regulatory requirements and guidelines. Requires subject matter expertise and demonstrated working knowledge of ICH, HHS, and FDA regulations pertaining to the ethical conduct of research. Responsibilities include daily operational guidance to all SJHMC/BNI investigators requiring independent judgement and strong critical thinking skills relative to human subject research regulations to ensure the safe and ethical conduct of research.
Oversees all administrative functions of the Institutional Review Board (IRB) and provides support to the IRB Chairs and Members. Responsible for coordinating aspects of the IRB functions and activities, including scheduling and logistics for meetings, inspections and training sessions.
Ensure proper compliance with institutional policies and procedures to ensure Dignity Health's compliance with Federal, State and local laws/regulations. Facilitates appropriate review for confirmation of scientific and statistical validity.
Liaison between IRB Chair, IRB committee members, investigators, Research Program Managers, Accountable Executives, Administration, Legal department, Corporate Compliance departments, as well as government officials and institutional officials.
Maintain in-depth knowledge of frequently changing federal regulations and guidelines, and other literature related to human subject protection.
Support IRB and membership to assure efficient processing of communications.
Support investigators and key study personnel in verifying completeness of IRB submissions.

Requirements

• Associates Other and/or equivalent combination of education and experience and Three to five years of related experience required upon hire
• Experience in the area of biosafety, animal care and use, institutional ethics review, research administration, audit or otherarea of research, compliance or oversight.
• Bachelors Degree required

Nice To Haves

• Five + years of related experience
• Clinical Research Associate
• Certified Clinical Research Coordinator ACRP
• Certified Clinical Rearch Coordinator SCRA

Responsibilities

• Oversees the day-to-day operations of the Institutional Review Board (IRB) in accordance with all applicable institutional, state, federal and other regulatory requirements and guidelines.
• Oversees all administrative functions of the Institutional Review Board (IRB) and provides support to the IRB Chairs and Members.
• Responsible for coordinating aspects of the IRB functions and activities, including scheduling and logistics for meetings, inspections and training sessions.
• Ensure proper compliance with institutional policies and procedures to ensure Dignity Health's compliance with Federal, State and local laws/regulations.
• Facilitates appropriate review for confirmation of scientific and statistical validity.
• Liaison between IRB Chair, IRB committee members, investigators, Research Program Managers, Accountable Executives, Administration, Legal department, Corporate Compliance departments, as well as government officials and institutional officials.
• Maintain in-depth knowledge of frequently changing federal regulations and guidelines, and other literature related to human subject protection.
• Support IRB and membership to assure efficient processing of communications.
• Support investigators and key study personnel in verifying completeness of IRB submissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees