Emory Healthcare/Emory University Senior Administrator, Data Safety and Monitoring Committee- Winship Cancer Institute in Decatur, Georgia
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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.
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 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 counseling.
Other duties as assigned.
The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
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.
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.
NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
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Job Number 83292
Job Type Regular Full-Time
Division Exec.V.P. for Health Affairs
Department Winship Clinical Trials
This position may involve the following Health and Safety issues: Not Applicable
Job Category Business Operations
Campus Location (For Posting) : City Decatur
Location : Name Winship Clairmont Admin Annex
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