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IRB - Human Research Regulations Specialist

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Managerial/Professional
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138445 Requisition #
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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.

Analyzes research applications and controverted issues received by Human Subjects Protection for regulatory compliance, and recommends appropriate revisions. Ensures proper administrative handling of the submitted research application and controverted issues for review by the Institutional Review Board (IRB). Provides specialized technical assistance to MD Anderson Cancer Center faculty and staff for research applications. Prepares and maintains documentation of IRB determinations made for submitted research applications.  Enters and maintains data into the regulatory systems.  Creates complex reports for use in reviewing specific application information and general trends. Collects metrics and participates in department quality assurance. Develops recommendations on operations and processes. May design and provide education training sessions for faculty, draft institutional communications and/or act as a coach and team leader.

JOB SPECIFIC COMPETENCIES

Expert knowledge support for IRB human research regulations  

Provides administrative support for the IRB office pertaining to the IRB meeting process

Prepares the IRB meeting agenda to include all items requiring convened board review based on MD Anderson IRB policies and the federal regulations.  Provides all necessary protocol documentation to the convened board.

Conducts the review of all agenda items to note any regulatory issues or potential controverted issues for the following: 1) new protocols; 2) amendments/modifications; 3) reportable new information (audits, monitoring reports, DSMB reports, unanticipated problems, protocol deviations/violations). 

Compiles all pertinent information from new protocols, and reports for the IRB designated reviewer and for placement on the IRB agenda.

Knowledgeable regarding IRB policies and federal regulations so as to note to the convened board any regulatory issues present in any items placed on the agenda. 

Provides staff support for the IRB meetings with regards to meeting logistics. 

Accurately documents convened board discussion which will include all IRB actions and discussion related to those actions.

Ensures compliance within designated timeframes and timelines for continuing review.

Provide accurate and timely information to the institutional research faculty and staff and IRB Members related to IRB actions

Utilize literature and seminars to expand knowledge of regulations governing human subjects research. 

Participate in training sessions for MDACC research faculty and staff as necessary to foster an environment that enhances compliance to the human subject protection regulations.
Develop and ensure documentation of departmental processes  Ensures appropriate documentation is maintained and current for standard operating procedures (SOPs) and IRB processes as mandated by the Code of Federal regulations governing human subjects research and MD Anderson IRB policies.  Complies with SOPs to ensure regulatory compliance.

Finalizes IRB documentation that includes entry of IRB determinations into regulatory databases.  Ensures that all regulatory data that reflect IRB outcomes and administrative actions are entered accurately into the regulatory databases .  Maintains all IRB determinations not reflected within the regulatory databases.
 

Education

Required: High school diploma or equivalent.

Preferred: Bachelor's degree

Experience

Required: Five years related experience, with specific experience in supporting administrative or research projects. May substitute equivalent years of preferred education for required experience on a one to one basis.

Preferred: Must have Research Institutional Review Board (IRB) experience.

 

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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