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 logístical aspects and assisting with facilitation.
Interfaces 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.
Essential functions:
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.
Manages project specific training and the set-up, maintenance and archival of
program files; ensuring pv remains audit ready.
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.
Oversees 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. Summarized purpose:
provides 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 honoraia 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 working knowledge of the event adjudication system. Obtains and tracks 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 manage all contracted services for dsmb/cec.
Qualifications:
education and experience:
high / secondary school diploma or equivalent and relevant formal academic / vocational qualification technical positions may require a certificate
previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).