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.
The IRB Coordinator 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. JOB SPECIFIC COMPETENCIES Manage and conduct review of submissions to OHSP (Office of Human Subjects Protection) - 40%
· 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.
· 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 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. Serve as IRB Subject Matter Expert - 40%
· 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.
· Guide investigators on process and regulatory requirements, when they plan to use MD Anderson IRB as the IRB of record for external sites
· 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. 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 Required: One year of experience in IRB administration, clinical research or human subject protection, regulatory compliance or research related job. May substitute required education with related human subjects protection and/or research administrative experience on a one to one basis. 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.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
Requisition ID: 167860 Employment Status: Full-Time Employee Status: Regular Work Week: Days Minimum Salary: US Dollar (USD) 58,000 Midpoint Salary: US Dollar (USD) 72,500 Maximum Salary : US Dollar (USD) 87,000 FLSA: exempt and not eligible for overtime pay Fund Type: Hard Work Location: Remote Pivotal Position: Yes Referral Bonus Available?: Yes Relocation Assistance Available?: Yes Science Jobs: No #LI-Remote
