PRAHS

Clinical Study Assistant

Job Locations (All)-- | TR
Posted Date 4 weeks ago(10/25/2024 8:10 AM)
ID
2024-114358

Overview

As a CSA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

  • The Global Clinical Study Assistant MAO, assists with local project management activities of clinical trials from start-up through to closeout activities. Work in close collaboration with the Global Trial leader (GTL) to ensure overall study delivery at the country level.

    • Schedules study management team meetings for each project assigned and maintains documentation from meetings.
    • Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
    • Ensures study compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring upto-date, complete and accurate status.
    • Maintains internal project specific study sites to ensure availability of all central project documents.
    • Liaises with external service providers and contract research organizations as needed.
    • Keeps oneself inspection ready and knowledgeable for current work by complying with relevant
      training requirements.
    • Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
    • Full utilization by timely and accurate time reporting.

Qualifications

What do you need to have?

  • Bachelor’s degree or equivalent experience
  • Excellent independent time management skills.
  • Experience in clinical research experience in the pharmaceutical industry or CRO. At least 1 year in a CTA role.
  • Fluency in English

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