• Clinical Trial Associate - Boston, MA

    Job Locations (All) | US-MA-Boston
    Posted Date 3 months ago(8/31/2018 1:24 PM)
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?


    Because we’re hoping you’re here for the latter.


    Who are we?

    We Are PRA.


    We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.


    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Trial Associate, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.


    Still here? Good. Because if this is you, we’d really like to meet you.


    What will you be doing?


    As a Clinical Trial Associate , you will assists the Clinical Project Managers in the conduct of trials and may be responsible for managing startup activities, vendor communication or other project activities as assigned. He/She performs work within established protocols under general supervision.


    • Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision
    • Assists Clinical Project Manager in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned
    • Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
    • Assists the Clinical Project Manager in ensuring compliance with Clinical Study Protocol and provides timely updates to assigned Clinical Project Manager to confirm compliance
    • Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
    • May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial
    • Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
    • May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
    • Performs other duties as assigned


    What do you need to have?


    Education:  B.S. (or equivalent experience) and 1 – 4 years of relevant work experience


    • 3+ years of related experience
    • Substantial experience using computerized information systems, electronic mail, word processing and electronic spreadsheets required.
    • Proven clinical research experience required.
    • Through knowledge of ICH and local regulatory authority drug research and development regulations required.
    • Experience leading a team in a clinical research environment required.
    • Experience leading a team on global clinical trials preferred.
    • Read, write, and speak fluent English;
    • Experience with PC-Windows, word processing, and electronic spreadsheets required.
    • Knowledge of ICH and local regulatory authority drug research and development regulations required.
    • Clinical trials support or pharmaceutical industry experience required.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.


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