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

Emory University•Brookhaven, GA

21h

About The Position

Winship Cancer Institute is seeking qualified candidates for the Senior Administrator, DSMC. 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).

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.

Nice To Haves

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.

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
Fulfilling 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.
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
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.
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 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.
Seek out new practice methods and principles, applying them to existing clinical research practices.
Assists the program and offices in complying 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 demonstrate facilitative leadership to foster productive teamwork through coaching, mentoring, and couseling.
Other duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.