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.