Irb Coordinator - Houston, United States - MD Anderson Cancer Center

MD Anderson Cancer Center

Verified Company

Houston, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

The mission of The University of Texas M. D.

Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

JOB SPECIFIC COMPETENCIES

Manage and conduct review of submissions to OHSP (Office of Human Subjects Protection) - 40%

Oversee entire process of submission from prereview to completion/approval, moving submissions through the workflow in a timely manner.
Oversee process for reliance managing and reviewing submissions going to an external IRB as well as site submissions when MD Anderson serves as the IRB of record
Provide consultation on and manage submissions to ensure they are IRB review ready using regulatory knowledge and expertise.
Conduct certain noncommittee reviews, serving as IRB members, using regulatory knowledge and expertise.
Identify, through independent discretion and judgment, the expertise required for the review and assign reviewers as appropriate.
Responsible to assure studies will be conducted in compliance with federal regulations, state regulations and institutional policy through evaluation of submitted materials with policies and regulations.

Serve as IRB Subject Matter Expert - 40%

Guide investigators on process and regulatory requirements, when they plan to use MD Anderson IRB as the IRB of record for external sites
Develops and provides training and education on Human Subjects Protection regulations to IRB members and study teams.
Maintain thorough understanding and up to date knowledge of all applicable regulations, including but not limited to FDA (Food and Drug Administration), HHS (Health and Human Services), OCR (Office of Civil Rights), DoD (Department of Defense), GCP (Good Clinical Practice), Texas state law
Participate in quality assessment and improvement activities, as needed.

Facilitate IRB Meetings - 20%

Provide regulatory expertise to assure meetings are run in compliance with regulations.
Ensure appropriate regulatory decisions are made during convened meetings.
Create and communicate complex IRB decisions to study teams after an IRB meeting.

Other duties as assigned

Education

Required:
Bachelor's degree.

Experience

Certification/Licensure

Required:
Certified IRB Professional (CIP) from the Public Responsibility in Medicine and Research (PRIM&R) within 180 days of eligibility.

Must pass pre-employment skills test as required and administered by Human Resources.
Additional Information