Title: Senior Administrator, Data Safety and Monitoring Committee (HYBRID)
Company: Emory University Winship Cancer Institute
Location: Atlanta, GA
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 Senior Administrator, DSMC is responsible for: 1) 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 2) 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).
- Tracking 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....
- Bachelors degree in a related field (scientific or health related) and seven years experience in clinical trials management, sponsored research, or regulatory management, including five years trial or related monitoring experience OR an equivalent combination of education and experience.
- Certification by Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) is required within three (3) years of hire.
To apply for this position or to learn more, please click "Apply Online" below.
SOCRA Exp: 8/5/2022