Senior IRB Coordinator

%3Cp%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3ESenior 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.%3C/span%3E%3C/p%3E%3Cp%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3EThe candidates within the Human Subjects Protection Department will be considered.%3C/span%3E%3C/p%3E%3Cp%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cstrong%3EJOB SPECIFIC COMPETENCIES%3C/strong%3E%3C/span%3E%3C/p%3E%3Cp%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cstrong%3E1. Manage and conduct review of submissions to OHSP (Office of Human Subjects Protection) – 30%%3C/strong%3E%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Interprets and applies federal and state laws, regulations, institutional policies, and guidelines to %26nbsp;protect human subjects and ensure compliance.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Oversees entire process of submission from pre-review to completion/approval %26nbsp; moving submissions through the workflow in a timely manner.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Provides consultation on and manage submissions to ensure they are IRB review ready using regulatory knowledge and expertise.%26nbsp;%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Conducts non-committee reviews, serving as IRB member, using regulatory knowledge and expertise.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Identifies, through independent discretion and judgment, the expertise required for the review and assign reviewers as appropriate.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Assures studies will be conducted in compliance with federal %26nbsp;regulations, state regulations, and institutional policy through evaluation of submitted materials with policies and regulations.%3C/span%3E%3C/p%3E%3Cp%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cstrong%3E2.%26nbsp;%26nbsp;Serve as IRB subject matter expert – 50 %%3C/strong%3E%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Leads quality assurance and quality improvement initiatives through collaboration with the QA specialist.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Evaluates implementation of new policies and/or processes.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Serves as preceptor for IRB coordinators, supporting the manager with training and onboarding of new IRB coordinators.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;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.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Identify need for new and revised policies and guidance to assure adequate subject %26nbsp; %26nbsp; protections and compliance with applicable regulations and guidelines, in collaboration with IRB Manager and OHSP Director.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Develop new and revised policies and guidance.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Identifies needs and develops training and education on Human Subjects Protection regulations to study teams in collaboration with IRB coordinators.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;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%3C/span%3E%3C/p%3E%3Cp%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E%3Cstrong%3E3.%26nbsp;%26nbsp;Facilitate IRB meetings – 20%%3C/strong%3E%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Provides regulatory expertise to assure meetings are run in compliance with regulations.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Ensures appropriate regulatory decisions are made during convened meetings.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Creates and communicates complex IRB decisions to study teams after an IRB meeting.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;Assesses needs, develops, and facilitates monthly education sessions on relevant IRB review topics to IRB members at IRB meetings.%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:Arial, Helvetica, sans-serif;font-size:14px;%22%3EOther duties as assigned%3C/span%3E%3C/p%3E

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

Job Details Employment Status: Full-Time Organization: SVP, Chief Scientific Officer 710920 Employee Status: Regular Work Locations: Houston (TX Med Ctr), 1515 Holcombe Boulevard, Houston, 77030 Work Location: Remote Job Code: 07026 Salary (Pay Basis): 68,500.00 Salary Midpoint: 85500 Salary Maximum: 102,500.00 Fund Type: Hard Work Week: Days FLSA: exempt and not eligible for overtime pay

Bachelor's degree required; two years IRB administration experience; CIP certification required within 180 days; must pass pre-employment skills test; may require security screening for critical infrastructure.

Key Responsibilities

• reviewing submissions
• serving as subject matter expert
• facilitating IRB meetings

Job Details

• Category: Healthcare Services - Allied Health
• Seniority: Mid Level
• Commitment: Full Time
• Workplace: Remote — Houston, Texas, United States
• Salary: USD 68,500 – 102,500 / year
• Languages: English

Benefits

• Generous paid time off
• Tuition reimbursement
• Retirement plan

About MD Anderson Cancer Center

A comprehensive cancer center providing patient care, research, education, and prevention. — Industry: Healthcare

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