Sr IRB Coordinator

Senior IRB Coordinator supports the IRB manager to ensure ethical conduct of research with human subjects through quality assurance and training initiatives The Senior IRB Coordinator serves as resource for faculty, researchers, and OHSP staff, providing expertise in regulatory requirements, guidance on protocol submissions, and support for the research community.

The candidates within the Human Subjects Protection Department will be considered.

JOB SPECIFIC COMPETENCIES

• Manage and conduct review of submissions to OHSP (Office of Human Subjects Protection) – 30%
• Interprets and applies federal and state laws, regulations, institutional policies, and guidelines to protect human subjects and ensure compliance.
• Oversees entire process of submission from pre-review to completion/approval moving submissions through the workflow in a timely manner.
• Provides consultation on and manage submissions to ensure they are IRB review ready using regulatory knowledge and expertise.
• Conducts non-committee reviews, serving as IRB member, using regulatory knowledge and expertise.
• Identifies, through independent discretion and judgment, the expertise required for the review and assign reviewers as appropriate.
• Assures 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 – 50 %
• Leads quality assurance and quality improvement initiatives through collaboration with the QA specialist.
• Evaluates implementation of new policies and/or processes.
• Serves as preceptor for IRB coordinators, supporting the manager with training and onboarding of new IRB coordinators.
• Advises, 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.
• Identify need for new and revised policies and guidance to assure adequate subject protections and compliance with applicable regulations and guidelines, in collaboration with IRB Manager and OHSP Director.
• Develop new and revised policies and guidance.
• Identifies needs and develops training and education on Human Subjects Protection regulations to study teams in collaboration with IRB coordinators.
• Maintains 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
• Facilitate IRB meetings – 20%
• Provides regulatory expertise to assure meetings are run in compliance with regulations.
• Ensures appropriate regulatory decisions are made during convened meetings.
• Creates and communicates complex IRB decisions to study teams after an IRB meeting.
• Assesses needs, develops, and facilitates monthly education sessions on relevant IRB review topics to IRB members at IRB meetings.

Other duties as assigned

EDUCATION

Required: Bachelor's Degree

WORK EXPERIENCE

Required: Two years IRB administration experience.

May substitute required education degree with related human subjects protection and/or research administrative experience on a one to one basis.

LICENSES AND CERTIFICATIONS

Required: CIP - Certified Institutional Review Board - IRB Professional Public Responsibility in Medicine and Research (PRIM&R). within 180 Days

Preferred: Certified IRB Professional (CIP)

OTHER REQUIREMENTS: Must pass pre-employment skills test as required and administered by Human Resources.

The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.

This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.

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