PRAHS

  • Senior Clinical Research Associate

    Job Locations (All) | Australia-Sydney
    Posted Date 3 days ago(1/13/2019 11:29 PM)
    ID
    2019-51341
  • Overview

    Senior Clinical Research Associate

    Location: Sydney/Melbourne, Australia

     

    As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

     

    At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

     

    At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community. 

     

     

    Responsibilities

    Working fully outsourced to one of our global client, the Clinical Research Associate (CRA) is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.

     

    With full ownership of investigator sites for assigned studies, the CRA's involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, the CRA fosters effective relationships with investigator site staff to ensure that key clinical metrics are met. This involves establishing innovative ways of increasing site and patient recruitment. When issues do occur, the CRA proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. The CRA may also design and deliver training to site staff, when appropriate.

     

    Typical duties for a CRA will likely include preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues that have occurred at site. The CRA ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.

     

    Operating as a key part of a global study team, the CRA plays a fundamental role in our client’s drug development process. 

    Qualifications

    You are:

     

    An experienced, ambitious self-starter looking for the opportunity to prove yourself in an embedded role within a pharmaceutical company.

     

    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:

    • At least 3-5 years independent monitoring experience is required for the successful candidate.
    • Prior working exposure in a CRO environment and knowledge of ICH-GCP guidelines as well as submission is however essential.
    • Fluency in English and an ability to communicate effectively with others, and good time management would be key.

     

    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.

     

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace. 

     

    For more information please visit our website: www.prahs.com

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