Safety Monitor - Project Manager

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.

The primary purpose of the Project Manager, IND Office position is to provide departmental administrative support, management interface and quality assurance expertise to ensure compliance with regulatory agencies, and to plan and direct activities involved with human subject research involving investigational new drug (IND) sponsored research trials.

JOB SPECIFIC COMPETENCIES

IND/IDE Management
Provides protocol review, regulatory document preparation, and support to investigators planning to conduct clinical trials under an MDACC sponsored IND beginning with formal review process, regulatory filing, conduct, and facilitates Monitoring Visits Reports workflow.

IND/IDE Sponsorship and Communications
Serves as the sponsor representative on all communications with federal agencies, research teams and maintains detailed documentation of all communications on MDACC sponsored IND studies. Represents the IND Office Medical Monitor during study specific activities and meetings.

Regulatory Resource for department and institution
Serves as resource to regulatory coordinator within the department as well as investigators and other research staff regarding current institutional policy and state and federal laws related to research; provides support to safety monitoring and filling to federal agencies.

Education

Required: Bachelor's degree in a Nursing, Healthcare Administration, Business Administration or related field.

Preferred Education: Master's Level Degree

Experience

Required: Eight years of professional experience to include three years of human subject research in regulatory compliance. With preferred degree, six years of required experience.

Preferred Experience: Eight years of experience in a health care management position.

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