Data & Safety Monitoring Coordinator

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2018 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

Function: Responsible for the review and analysis of newly submitted protocols for data safety monitoring.

Job Responsibilities:

Responsible for the review and analysis of newly submitted protocols to the Scientific Review Committees for data monitoring.

Enters and maintains pertinent data into the MD Anderson regulatory systems.

Ensures compliance of all protocols flagged for Data and Safety Monitoring Committee (DSMC) review.

Notify PIs and their Regulatory Staff of upcoming review of protocols by generating reports and sending out templates along with deadlines for when the responses need to be submitted.

Ensures that PI / Research Staff are operating within timeframes to ensure that meeting process deadlines are met.

Conducts thorough administrative reviews to ensure all pertinent information in which the PI has submitted is there for the committee to make their decision.

Uses independent judgment to make sure all information is filled out correctly and facilitates obtaining corrections when necessary.

Facilitates review of protocols through the DSMC including review of safety information, as well as internal audits findings.

Provides administrative support before, during and after all DSMC meetings, including generation of relevant reports, notifications to faculty, scheduling meetings virtually or in person, development of agendas, setting up and attending the monthly DSMC committee meetings through the virtual meeting platform, maintenance of committee roster and electronic meeting binders.

Collaborates with Committee to write and submit meeting outcome memos and communicates these outcomes to researchers and Office of Clinical Research teams.

Collects metrics for the Data and Safety Monitoring Process. Must have strong proficiency in Excel and be capable of independently generating reports and metrics.

Collaborates with Leadership within the Office of Clinical Research. to identify quality improvement opportunities and programming needs.

Other duties as assigned.

Education
Required: Bachelor's degree in a related field.

Experience
Required: Two years of experience in a clinical research setting supporting administrative or research projects. May substitute equivalent years of preferred education for required experience on a one to one basis.

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. [Register to View] Information

• Requisition ID: 150437
• Employment Status: Full-Time
• Employee Status: Regular
• FLSA: exempt and not eligible for overtime pay
• Work Week: Days
• Fund Type: Hard
• Work Location: Hybrid Onsite/Remote
• Pivotal Position: No
• Minimum Salary: US Dollar (USD) 54,500
• Midpoint Salary: US Dollar (USD) 68,000
• Maximum Salary : US Dollar (USD) 81,500
• Science Jobs: No