Work Schedule

Third Shift (Nights)

Environmental Conditions

Office

Job Description

Performs moderate day-to-day committee activities for Clinical Endpoint Committees (CEC) and/or Data Safety Monitoring Boards (DSMB) within a highly regulated environment. Displays a working knowledge of the procedures and electronic platforms/ software systems used for direct communications with the CEC and/or DSMB committees and other external and pre-existing software systems. Effectively collaborates with various parties such as: project team members, data management, biostatistics, client contacts, investigators, committee members, and third-party vendors.

A day in the Life:

Initiates CEC/DSMB study start-up activities (charter development, member Contracting, electronic adjudication system build).Completes CEC/DSMB close-out activities.Performs day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures.Reviews adjudication/DSMB publications and information sources to keep updated on current regulations, practices, procedures and proposals related to Changes in CEC and DSMB practices.Maintain medical understanding of applicable therapeutic area and disease states.Prepares and QCs CEC dossier completion and submission.Maintains secure files for DSMB unblinded data.Assists with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget Considerations as they relate to specialty committee activities.May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings Representing the CEC and/or DSMB specialty committee functions.