IRB Administrator - Clinical Research Center - PRN

Stormont-Vail Healthcare • Topeka, KS

418d • Onsite

About The Position

The Institutional Review Board (IRB) Administrator at Stormont Vail Health serves as the primary administrative support for the Institutional Review Board (SVIRB). This role involves managing compliance with regulations from the Office of Human Research Protections and the Food and Drug Administration, supporting IRB submissions, and serving as a resource for research regulations. The position is part-time and operates on a PRN basis, meaning hours are not guaranteed and the role is not benefit-eligible.

Requirements

• High School Diploma or GED required.
• Bachelor's Degree preferred.
• 1 year of clerical experience in a healthcare or research facility required.
• Experience in human subjects research preferred.
• Training in human research protections preferred.
• Ability to read and interpret research protocols and federal regulations.
• Proficiency in Microsoft Office, Outlook, and electronic medical records.
• Good written communication skills.

Nice To Haves

• Certification as an IRB Administrator preferred.

Responsibilities

• Review initial IRB submissions from investigators for completeness and compliance with regulations.
• Evaluate expedited review, emergency use, and continuing review submissions from investigators.
• Communicate with investigators regarding submissions and IRB decisions.
• Document SVIRB meetings in compliance with regulatory requirements.
• Organize and communicate necessary information to primary reviewers and about monthly IRB meetings.
• Maintain records of all protocols under SVIRB oversight.
• Maintain expert knowledge on IRB regulations and protections for human research subjects.
• Prepare regulatory submission packages for IRB review, including necessary documentation.
• Work with the department director on IRB submission application forms and subject reimbursement requests.
• Communicate frequently with sponsors, IRBs, and clinical research associates.

What This Job Offers

• Job Type: Part-time
• Industry: Ambulatory Health Care Services
• Education Level: High school or GED