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

About the role

The Senior Administrator, Data Safety and Monitoring Committee (DSMC) at Winship Cancer Institute of Emory University supports and coordinates the Data Safety and Monitoring Committees (DSMC) in following the Winship Data Safety and Monitoring Plan (DSMP).

Responsibilities

• 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;
• Fulfills the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators.
• Process, review, and assess SAE, device incident, and pregnancy reports from clients' ongoing drug or device clinical trials in a timely manner.
• Maintain, revise, and oversee the Data Safety and Monitoring Plan (DSMP); racking and evaluating monitoring trends for IITs and reporting the trends to Winship CTO Leadership.
• Partner 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.
• Independently verify submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment.
• Celebrates the success of the Cancer Center's protocol review and monitoring process by coordinating and attending Data Safety and Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines.
• Prepares DSMC documents in collaboration with the study PI, including confidentiality agreements, conflict of interest statements and charters for each study requiring DSMC review.
• Disseminates policy decisions and resolutions to Winship study teams from the Data Safety and Monitoring Committees.
• Takes on special projects or tasks as required and needed.
• Ensures orientation and training policies for investigators comply with local and federal regulations and accreditation standards.
• Seeks out new practice methods and principles, applying them to existing clinical research practices.
• Affirms compliance with all accreditations, legal, regulatory, and safety requirements.
• Uses group participation skills when working as a member of a committee or informal work group.
• Participates actively and positively on assigned committees.
• Accurately identifies opportunities for improvement.
• Actively demonstrates facilitative leadership to foster productive teamwork through coaching, mentoring, and counseling.

Requirements

• Bachelor's degree in a related field (scientific or health related) and seven years of 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.

Qualifications

• Previous supervisory experience.
• Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
• Experience with good clinical practices and clinical trials development or implementation.
• Familiarity with Clinical Trials Monitoring Systems (CTMS).
• Experience as a clinical manager, operations manager, or general manager.
• Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
• Experience in indirect management of team members, including assisting in the development, training, and assignment of work/projects to other team members.