Global Trial Acceleration Associate
Core
Managing and executing centralized clinical trial activities with an emphasis on clinical documentation, site activation, and regulatory submissions.
Role type
Individual contributor clinical trial operations associate
Builds
Global clinical trials (start-up, maintenance, close-out)
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical documentation management, Site activation, Regulatory submission support, Vendor/CRO coordination, Essential document collection, Quality control of start-up activities, Clinical system updates (CTMS, eTMF), Certified translation coordination, Investigator debarment tracking
Preferred skills
None stated
Technologies
CTMS, eTMF
Responsibilities
Manage and execute centralized activities in support of global trials with an emphasis on clinical documentation; Interact with clinical study sites, CROs/vendors, Country Trial Managers, and the study team; Serve as the main point of contact for essential document management and ethical/regulatory submission activities; Support outsourcing activities by interfacing with operational teams and service providers; Initiate and manage start-up documentation activities for global clinical trials; Submit potential investigators to CTSS for debarment review; Responsible for country/Site Activation including final review of documents and sign-off of checklists; Update and review various study-related clinical systems to determine and report status of clinical trial documents; Arrange certified translation of study level documentation; Assist with the coordination or creation of study specific materials such as pharmacy or Investigator site file; Act as single point of contact for the study team for centralized activities during study start-up; Ongoing maintenance and tracking of essential documentation and collection of updated/outstanding documentation; Ongoing communication with study teams regarding centralized study activities; Maybe responsible for creation and management of standardized document templates; Assist with CSR distribution; Country and site level ICF adaptation; Centrally reviewing all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks.
