PRAHS

  • Clinical Trial Disclosure Associate

    Job Locations - | United Kingdom | United Kingdom-Swansea
    Posted Date 2 weeks ago(5/10/2018 5:01 AM)
    ID
    2018-46838
  • Overview

    At PRA, we don’t make our 15000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.

     

    We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do. Put simply, we care.

    Responsibilities

    Due to growth we are seeking 4 Clinical Trial Disclosure Associates to join our established Medical Writing team, based in either our Swansea or Reading offices.

     

    This entry level role will suit a recent graduate who is looking to take the first steps into a career in Clinical Research. Full training will be provided.

     

    The Clinical Trial Disclosure Associate writer executes trial transparency writing, redaction and quality control review activities in accordance with sponsor requirements and international regulations, working with scientists from multiple functions and partners worldwide such as Clinical Operations, Statistics, Medical and Scientific Affairs, Regulatory Affairs and Medical Writing to obtain and ensure accuracy of registration and results posting. 

     

    Responsibilities include;

    • Drafting registrations and results disclosure information and harmonizes content across multiple formats (tabular, synoptic, lay summary) in accordance with regional/national disclosure laws and client policy. Engaging study teams during protocol drafting in anticipation of public disclosure. 
    • Adhering to project plans and timelines for studies assigned
    • Redacting protocols, SAPs, CSRs and other applicable documents in support of trial transparency activities
    • Quality-control review of draft registrations and results, as well as protocols, SAPs, CSRs and other applicable documents in support of Medical Writing activities.
    • Supporting ad-hoc trial transparency projects.
    • May include other medical writing support including narratives and non-technical summaries of results.

    Qualifications

    You are:

     

    A strong communicator, a self-starter, detail-oriented

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

    • A PhD level qualification in a Medical Science, Statistics or Mathematics related subject; Masters level candidates considered with equivalent writing experience
    • Previous experience of writing publications
    • Familiarity with clinical protocols and basic knowledge of clinical study design 

     

    You will be frequently collaborating within multi-cultural global teams, so will need to demonstrate excellent written and oral communication skills, exhibit pro-active teamwork alongside a positive attitude, and maintain up-to-date industry awareness and understanding of regulation/standards.

     

    Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

     

     

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