The Research Program Manager, PRMS supports and coordinates the GW Protocol Review and Monitoring System Committees, namely Scientific Review Committees (SRC), Protocol Monitoring Committee (PMC) and Data Safety Monitoring Committee (DSMC). The manager will provide overall support and organization for all committee functions and responsibilities. Serves as a point of contact for all activities related to monitoring adherance to SRC/PMS policies and procedures as outlined in the Data Safety and Monitoring Plan (DSMP) adopted by GW Cancer Center as required by the Cancer Center Support Grant Guidelines (CCSG). The manager 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 data safety and monitoring plan; and 2) fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators.
-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. This function is carried out under the guidance of the Director of the CTO.
-Coordinates and attends Scientific Review, Protocol Monitoring and Data Safety 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 GW review committees, all of which are components essential to the success of the Core Grant.
-Prepares DMC documents in collaboration with the study PI, including confidentiality agreements, conflict of interest statements and charters for each study requiring DMC review.
-Disseminates policy decisions and resolutions to GW study teams from the Scientific Review or Protocol Monitoring Committees
-Takes on special projects or tasks as required and needed by the Director of the CTO.
-Other duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
For additional and specific job duties, responsibilities, requirements, and to apply, please visit: https://www.gwu.jobs/postings/85387