Safety Committe Admin

Job Description

Job Description

As a Safety Committee Admin, you are responsible to provide moderate contracted project coordination and safety support on global and domestic programs with an emphasis on Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (CEC). Performs DSMB/CEC set-up, member contract execution and tracking. Administers member payment set up, member honorary management and oversight, polls committee members and client Contacts for meeting dates and times. Arranges meeting facilities as needed for all contracted meetings and attends and completes meeting minutes for DSMB/CEC meetings as contracted. Provides oversight for all DSMB/CEC filing, assists the Safety Committee Specialist with dossier building and distribution and has a solid understanding of the Event Adjudication System. Acquires and supervises adjudication specific Documents for inclusion into dossier. In collaboration with Safety Committee Specialists, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate, and facilitate meetings and accurately run all contracted services for DSMB/CEC.

• Represents the DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the company's project team, coordinating all Logistical aspects and assisting with facilitation.
• Collaborate with various internal and external parties to implement contracted DSMB / Adjudication services for projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations, reviewing all contractual documents for accuracy, and coordinating internal and external approvals.
• Compiles/creates/submits follow-up to investigative sites. Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
• Handles project specific training and the set-up, maintenance and archival of Program files; ensuring PV remains audit ready.
• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the company's Data Privacy.
• Performs data entry into internal/external databases, tracking systems; performs system reconciliations to identify issues which may negatively impact project timelines.
• Supervises expenses including committee, travel or translation expenses ensuring proper escalation as needed for timely member payment.
• Supports any specific activities performed by the specialty committee team, which can be assisted by administrative support.