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Program Manager IRB - Protocol Research

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Managerial/Professional
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VP Clinical Research 710467
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120282 Requisition #
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.

Oversees the review and management of 1) non-compliance reports such as unanticipated problems, serious adverse events, and other reported information; 2) amendment activation for protocol amendments; and 3) metric reporting for the IRB.  Responsible for the design, execution and effectiveness of programs that will support the IRB initiatives.  Directs the preparation of reports and other documentation required for the IRB, the department and other programs.  Collaborates with all sections to provide applicable guidance and support to managers and staff. Acts as a consultant for institutional clinical research faculty and staff personnel on steps to follow for compliance of human subject research federal guidelines.

JOB SPECIFIC COMPETENCIES


OVERSEES THE REVIEW AND MANAGEMENT OF INITIATIVES FOR THE IRB 

Manages the following projects related to the human subjects research for the IRB.  

Manages non-compliance reports such as unanticipated problems, serious adverse events, and other reported information to ensure that the reports are triaged and reviewed by the IRB.  Ensures that the provided reports have closure and resolution.  

Manages the amendment activation for protocol amendment.   Ensures that IRB approval and institutional requirements are met for protocol amendments prior to implementation of the amendment by Principal Investigators and research teams.  

Manages the metric reporting for the IRB.  Responsible for reviewing amendment metrics as well as other IRB metrics to ensure that the established timelines are met.  Ensures that any delays are communicated to management so that mitigation steps can be implemented.


MANAGEMENT OF REPORTING REQUIRED BY THE IRB

Reviews reporting generated as part of the review of the non-compliance items, amendment activations, and IRB metrics

Validates the data included within the reports to ensure that data entry is done appropriately


MAINTAINS DEPARTMENT STANDARD OPERATING PROCEDURES FOR THE ESTABLISHED INITIATIVES 

Maintains operating procedures for the assigned initiatives.
  
Conducts self-audit of process and reports findings to leadership as needed.  

Assures appropriate documentation is maintained as mandated by the federal regulatory requirements.

Education
Required: Bachelor's degree.  

Preferred: Master’s degree in Business Administration, Healthcare Administration or related field

Experience
Required: Five years of related  program management experience. May substitute required education degree with additional years of equivalent experience or completed years of college on a one to one basis. With preferred degree, three years of required experience.

Preferred: Eight years of clinical research or regulatory experience to include three years of human subject research in regulatory compliance.  
 
Preferred Certification: Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), or other related regulatory licenses or certifications relevant to the position responsibilities.
 
 

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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