Manager, IRB

Employer
University of Texas MD Anderson Cancer Center
Location
Houston, Texas
Salary
Competitive
Closing date
Oct 12, 2022

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Discipline
Health Sciences
Organization Type
Healthcare/Hospital
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2018 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

Reporting to the OHSP Director, the OHSP Manager provides leadership support for the Office of Human Subjects Protection (OHSP), is responsible for oversight of at least 1 IRB committee/panel and multiple IRB Coordinators and serves as a liaison between the Director and OHSP staff. The IRB Manager has the primary responsibility for managing a team of IRB Coordinators and overseeing the activities that support committee and non-committee review of IRB submissions. This includes managing team workload, monitoring team productivity and reviewing and ensuring appropriate turnaround times, and ensuring that OHSP staff and IRB committee members are utilizing the HRPP Toolkit appropriately.

The IRB Manager is responsible for providing feedback and suggestions to the Director regarding the use of the HRPP Toolkit. The IRB Manager also serves as an alternate on the IRB and is a regulatory specialist designated to conduct expedited IRB reviews of research involving human subjects.

Responsibilities
  1. Oversee IRB Team Operations
  • Assure that the IRB committee/panel(s) and OHSP staff comply with the HRPP Toolkit which includes applicable local and federal regulations, rules, guidelines and ethical principles
    1. Perform duties as specified in the HRPP Toolkit
    2. Triage and assign submissions to IRB Coordinators
    3. Oversee IRB reviewer assignments and attendance to ensure appropriate expertise is present/available
    4. Work with other IRB Managers to coordinate activities as needed
    5. Conduct quality assurance reviews for IRB meeting minutes, non-committee review determinations and correspondence
  • Assist with training of new IRB members and serve as a contact for member questions/concerns for assigned panel(s)
  • Monitor OHSP staff productivity metrics and goals
  • Identify and address workflow issues as they arise so that quality and efficiency are optimally maintained
  • Investigate and answer regulatory questions from research community, including phone calls, emails and in-person requests
  • Conduct HRPP related training as needed
  • Interpret and apply federal regulations and any relevant state law to research submissions at all stages of HRPP review
  • Solve problems, conditions, circumstances that necessitate knowledge of regulations, guidelines, rules, ethical principles with enterprise and new approaches


  1. IRB Staff Management
  • Directly supervise IRB Coordinators on assigned team
  • Hold regularly scheduled staff meetings
  • Provide guidance regarding coordination and communication of the regulatory functions of HRPP
  • Evaluate OHSP staff performance to include assessing quality, productivity, and efficiency and provide ongoing feedback
  • Evaluate work volume: staff ratio and make recommendations to OHSP leadership when changes are required


  1. Perform IRB Reviews
  • Serve as an IRB alternate, as well as a designee of the Chair to conduct expedited review
  • Attend convened IRB meetings to provide guidance to IRB members and Chairs on regulatory requirements and perform reviews as needed
  • Perform non-committee reviews of IRB submissions


  1. HRPP Support and Development
  • Conduct presentations related to regulatory/human subjects protection topics or IRB process for groups or classes involved in the conduct of human subject research
  • Participate in the development and conduct of training on IRB-related issues for OHSP staff and IRB members
  • Attend regional and national conferences to pursue ongoing professional education and stay current on federal regulations, guidance and accreditation standards
  • Provide support for OHSP leadership as needed
  1. Other Duties as assigned.


Education
Required:
Bachelor's degree in a related field.

Experience
Required:
Five years of experience in human/animal research, medical care or regulatory affairs to include three years of supervisory/management experience. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience. May substitute required education with related human subjects protection and/or research administrative experience on a one to one basis.

Certification
Required:
Certified IRB Professional (CIP) from the Public Responsibility in Medicine and Research (PRIM&R).

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

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