Job Description

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.

SUMMARY

The primary purpose of the Safety Project Manager, IND Office is overall analysis of safety data as require by protocol design. Work with Investigators, clinical research organizations and commercial supporters to streamline safety information reporting.

KEY FUNCTIONS

IND/IDE Management (50%)

\xc2\xb7 Provides support to investigators planning to conduct a clinical trial under an MDACC sponsored IND by reviewing the safety content of a new protocol with a focus on the study design, dose limiting toxicities (DLTs) and unacceptable toxicities.

\xc2\xb7 Reviews, prepares, and submits safety reports to the FDA in accordance with federal regulations.

\xc2\xb7 Develops protocol specific stopping rule monitoring plans based on a protocol\xe2\x80\x99s statistical design.

\xc2\xb7 Conducts real-time safety monitoring to prevent or mitigate adverse events from the use of investigational drugs and devices associated with MDACC sponsored IND trials.

\xc2\xb7 Reviews and analyses protocol data pertaining to stopping rules. Provide guidance to study teams regarding dose-escalation, expansion, and/or study continuation based on findings from the data and the protocol design.

\xc2\xb7 Provides coverage for the Clinical Trials Safety Manager.

IND/IDE Sponsorship and Communications (25%)

\xc2\xb7 Represents MDACC as the Sponsor on all safety communication with federal agencies and research teams.

\xc2\xb7 Maintains detailed records of all safety documentation and correspondence between the Sponsor and the FDA.

\xc2\xb7 Works with Investigators to evaluate safety data and address complex safety issues.

\xc2\xb7 Represents MDACC as the Sponsor during study specific activities and meetings.

\xc2\xb7 Identifies and escalates serious safety issues and concerning trends.

\xc2\xb7 Conducts weekly quality assurance checks to ensure all SAEs were reviewed.

Regulatory Resource for department and institution (15%)

\xc2\xb7 Serves as safety regulatory resource to staff within the department as well as to clinical research monitors, investigators, commercial supporters and Clinical Research Organizations regarding current institutional policy and state and federal laws related to research.

\xc2\xb7 Conducts safety trainings for new MD Anderson IND Sponsored trials prior to activation.

\xc2\xb7 Serves as Preceptor for new safety project managers.

\xc2\xb7 Serves as a consultant on safety issues to the regulatory project managers, clinical research monitors, and other team members within the Office of Clinical Research, as needed.

\xc2\xb7 Provides formal and informal research education on safety topics including but not limited to SAE reporting and stopping rules monitoring to investigators and research staff through departmental and small groups training sessions.

Quality Improvement and Development (10%)

\xc2\xb7 Coordinates policy development, implementation, and completion to ensure regulatory compliance with federal, state, and local research safety laws, and policies related to institutional and departmental programs, with minimal oversight of the Manager or Director. Develops and maintains Standard Operation Procedures to assure consistent workflow.

\xc2\xb7 Designs and directs new initiatives, special administrative assignments, and programs, as assigned. Responsible for the design, execution, and effectiveness of quality assurance/control programs to improve the safety oversight for clinical trials.

\xc2\xb7 Ensures institutional compliance with federally mandated safety monitoring and reporting requirements by utilizing current clinical and research expertise and through continuing education.

Other duties as assigned.

MD Anderson Cancer Center