The mission of The University of Texas MD 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.

The primary purpose of this position is to provide start-up regulatory processes for departments participating in Phase I-V clinical trials. Employees in this title will prepare and process all regulatory documentation from submission through applicable regulatory review committees to activation.

JOB SPECIFIC COMPETENCIES

70% Regulatory Support

* Analyzes protocols prior to submission to determine what reviews the protocol will require, what specific documents must be included, and which committees must review the protocol.

* Interprets, and applies FDA regulations, NCI policies/procedures, and Good Clinical Practice guidelines while reviewing protocols and all related documents.

* Prepares and submits initial protocol submissions for IRB and external review committee approval.

* Acts as the primary contact/liaison for the regulatory processing of research protocols for all MDA departments participating in Phase I-V clinical trials. This requires prior knowledge of variety of treatment modalities.

* Provides guidance and communication regarding the regulatory status of clinical trials to department leadership and key stakeholders.

* Serves as a regulatory expert for clinical research departments and external entities.

* Works directly with the sponsor or contract research organization to address regulatory queries.

20% Quality Assurance

* Performs analysis of complex research processes and provides guidance and education to stakeholders to promote quality research outcomes.

* Modifies regulatory workflows as needed to ensure seamless communication between research teams and key stakeholders.

10% Educational Support

* Develops and delivers educational training programs regarding federal and institutional guidelines for compliance.

* Provide regulatory submission training to internal research teams for new and existing protocols.

* Create and share correspondence with internal and external entities regarding study specific updates and general guidance for regulatory processes.

Other duties as assigned

Education: Bachelor's degree

Preferred Education: Master's Level Degree

Experience: Two years of regulatory compliance experience or experience working as a research data coordinator. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.

Preferred Experience: Experience with oncology research pertaining to the conduct of clinical research trials

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