MD Anderson Cancer Center Project Manager, IND Office in Houston, Texas
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.
Provides departmental administrative support, management interface and quality assurance expertise to ensure departmental compliance with regulatory agencies. Plans and directs activities related to MD Anderson-sponsored IND/IDE research trials.
JOB SPECIFIC COMPETENCIES
Provides protocol review, IND/IDE content review, regulatory document preparation, and support to investigators planning to conduct clinical trials under an MD Anderson-sponsored IND beginning with pre-IND activities, protocol development, formal review process, regulatory filing, and activation, conduct, and closeout of the trial.
IND/IDE Sponsorship and Communications
Serves as the sponsor representative on all communications with federal agencies and maintains detailed documentation of all communications on MD Anderson- sponsored IND studies.
Regulatory Resource for Department and Institution
Serves as resource to investigators and other research staff, as well as to other project managers and research quality coordinators within the department, regarding current institutional policy and state and federal laws related to research; provides education to investigators and research teams on investigational new drugs, investigational devices, and gene therapy studies requirements and policies.
Required: Bachelor's degree in a Nursing, Healthcare Administration, Business Administration or related field.
Preferred: Master's degree.
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 with p reparation clinical protocol documents
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
Requisition ID: 140721
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days
Fund Type: Soft
Pivotal Position: Yes
Minimum Salary: US Dollar (USD) 68,400
Midpoint Salary: US Dollar (USD) 85,500
Maximum Salary : US Dollar (USD) 102,600
Science Jobs: No