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.
\xef\x82\xb7 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.
\xef\x82\xb7 Interfaces with various internal and external parties to implement projects,
prepares 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.
\xef\x82\xb7 Compiles adjudication dossiers and creates/submits follow-up to investigative
sites.
\xef\x82\xb7 Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded
and unblinded minutes/materials to client portals and distributes to internal and
external project teams.
\xef\x82\xb7 Manages project specific training and the set-up, maintenance and archival of
program files; ensuring PV remains audit ready.
\xef\x82\xb7 Identifies and redacts subject identifiers per local requirements, retrains sites
and escalates reoccurrences to the organization\'s Data Privacy.
\xef\x82\xb7 Performs data entry into internal/external datases, tracking systems and the
organization\'s budget management system; performs system reconciliations to
identify issues which may negativley impact project timelines.
\xef\x82\xb7 Oversees expenses and manages translations; ensuring budget parameters are
not exceeded.
\xef\x82\xb7 Answers incoming hotline calls, coordinates department functions and performs
other duties as assigned.
\xef\x82\xb7 Supports any specific activities performed by the local office, which cannot be
performed from elsewhere.
\xef\x82\xb7 Provides training to junior staff.