Catholic Health Initiatives IRB Analyst in ENGLEWOOD, Colorado

IRB Analyst

Description

Job Summary

The Institutional Review Board (IRB)

Analyst is key to the successful operation of the CHI CIRI IRB. The IRB Analyst

works independently to make various study determinations based on his/her regulations

knowledge and assists IRB Leadership in effective and efficient IRB operations

according to the CHI/CIRI policies and standard operating procedures.

Key Responsibilities

  • Review and process IRB applications and othersubmissions to determine whether the investigator has completely addressedall areas needed by the IRB; will communicate with the investigator andprovide them with guidance on how to fulfill those requirements; providefeedback to the investigator on privacy, confidentiality, risks, benefits,etc.; Determine which projects are ready for IRB review and communicateswith IRB reviews to identify potential problems than need addressed.35%

  • Assist IRB Leadership in the implementation andmaintenance of the IRB information management system. 20%

  • Attend IRB meetings to document IRB proceedings toprepare communications and minutes according to federal regulatoryrequirements and CIRI policies and procedures 5%

  • Prepare meeting agendas, review materials, meetingminutes, and IRB determination letters and communications in compliancewith federal regulations and CIRI policies and procedures. 25%

  • Participate in quality improvement initiatives 5%

  • Assure IRB expedited reviewer assignments are conductedefficiently and on time, notifying IRB Leadership as needed. 5%

  • Other duties, as assigned 5%

Qualifications

Education & Experience:

  • Bachelor’s degree required (in science/healthcarerelated field preferred).

  • Minimum of three (3) years of experience in IRBoperations required.

  • Required knowledge of federal regulations andinstitutional policies. Ability to apply that knowledge to thestudies.

  • Certified IRB Professional (CIP) preferred

  • Outstanding customer service skills required

Job Professional Non-Clinical

Primary Location COLORADO-ENGLEWOOD-DENVER INVERNESS

Daily Schedule Days

Scheduled Hours per 2-week Pay Period 80

Weekends Required None

Req ID: 2018-R0156743