IRB Coordinator

$58,000 - $87,000/Yr

University of Texas M.D. Anderson - Houston, TX

posted 6 days ago

Full-time - Entry Level
Houston, TX
Hospitals

About the position

This position provides regulatory expertise, guidance and support to the Institutional Review Board(s) (IRB). The IRB Coordinator is responsible for processing submissions according to policies and procedures and serves as a subject matter expert to support IRB review.

Responsibilities

  • Manage and conduct review of submissions to OHSP (Office of Human Subjects Protection)
  • Interpret and apply federal and state laws, regulations, institutional policies, and guidelines to protect human subjects and ensure compliance.
  • Oversee entire process of submission from pre-review to completion/approval, moving submissions through the workflow in a timely manner.
  • Provide consultation on and manage submissions to ensure they are IRB review ready using regulatory knowledge and expertise.
  • Conduct certain non-committee 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.
  • Advise, with appropriate independent judgement and discretion, IRB members, researchers and key personnel regarding Human Subjects Protection regulations and policy to assure protection of research subjects.
  • Develop, review and modify OHSP policies assure adequate subject protections and compliance with applicable regulations and guidelines.
  • Assess, recommend and implement OHSP policies and procedures as appropriate, assuring compliance and protection of human subjects.
  • 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.
  • 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.

Requirements

  • Bachelor's degree.
  • One year of experience in IRB administration, clinical research or human subject protection, regulatory compliance or research related job.
  • 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.

Benefits

  • Referral Bonus Available
  • Relocation Assistance Available
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