Job Description
Coordinates the timely review of protocol inquiries, serious and non-serious
adverse events, diagnostics and Data Safety Monitoring Board data; tracks all
necessary data and generates reports for the client, project team and/or external
vendors.
Represents the organization's 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 project team,
coordinating all logistical aspects and assisting with facilitation.
Interfaces with various internal and external parties to implement projects,
prepares Confidentiality Disclosure Agreements, Letters of Intent and Member
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Agreements based on contractual considerations; reviewing all contractual
documents for accuracy and coordinating internal and external approvals.
Compiles adjudication dossiers and 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.
Manages 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 organization's Data Privacy.
Performs data entry into internal/external databases, tracking systems and the
organization's budget management system; performs system reconciliations to
identify issues which may negatively impact project timelines.
Oversees expenses and manages translations; ensuring budget parameters are
not exceeded.
Supports any specific activities performed by the local office, which cannot be
performed from elsewhere.
Provides training to junior staff.