Senior Administrator, Data Safety and Monitoring Committee- Winship Cancer Institute

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About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute‑designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer.

Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient’s needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu.

Winship is seeking qualified candidates for the Senior Administrator, DSMC. Position details are as follows:

JOB DESCRIPTION:

• The Senior Administrator, Data Safety and Monitoring Committee (DSMC) at Winship supports and coordinates the Data Safety and Monitoring Committees (DSMC) in following the Winship Data Safety and Monitoring Plan (DSMP).
• Responsible for providing quality data in order to respond to the DSMP requirements.
• Provides overall support and organization for all committee functions and responsibilities.
• Serves as a point of contact activities related to monitoring adherence to DSMP and policies and procedures adopted by Winship Cancer Institute as required by the Cancer Center Support Grant Guidelines (CCSG).

The Sr Administrator, DSMC is responsible for:

• The preparation of the agenda and review of materials prior to the committee meeting to assure that material required for review are available in accordance with the DSMP; and
• Fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators.

Responsibilities include the following duties:

• Process, review, and assess SAE, device incident, and pregnancy reports from clients’ ongoing drug or device clinical trials in a timely manner. Responsible for the maintenance, revision and oversight for the Data Safety and Monitoring Plan (DSMP)
• racking and evaluating monitoring trends for IITs and reporting the trends to Winship CTO Leadership
• Partnering with Training/Education to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards
• Ensure compliance with all applicable regulations and timelines for safety case processing and reporting
• Responsible for thorough assessment of required data entry elements and timely accurate input of that data into the Clinical Trials Management System (CTMS) to facilitate efficient project management. This responsibility commences at the original point of project entry, continues through original IRB approval and Activation of the project, and is sustained through periodic monitoring of accuracy and clarity of data elements
• Independently verifies submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment.
• Coordinates and attends Data Safety and Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines to ensure the success of the Cancer Center’s protocol review and monitoring process.
• Responsible for compiling agendas, assigning committee reviewers, composing official minutes, and constructing reports and correspondence in final form for Winship review committees, all of which are components essential to the success of the Core Grant
• Prepares DSMC documents in collaboration with the study PI, including…