PRAHS

  • Clinical Research Associate - Shanghai, Hangzhou, Suzhou, Nanjing

    Job Locations - | China
    Posted Date 3 months ago(1/28/2018 1:42 AM)
    ID
    2018-44746
  • Overview

    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.
    PRA Health Sciences Shanghai China is currently looking to hire experienced Clinical Research Associate (CRA) to join our business and fully integrated into one of our (exclusive) strategic global partners, via our Strategic Solutions Division. Our aim in Strategic Solutions Division is to deliver the customized services to our global partners with our customized solutions designed to manage large and mid-size biopharmaceutical companies’ pipeline portfolios more efficiently and with greater flexibility and control. Reporting into a Clinical Operations Manager, you will be responsible for clinical trial activities from site initiation to routine monitoring and close-out of clinical trials. A proven Clinical Research Associate (CRA) with minimum 2 years of independent multi-site monitoring experience is expected.
    Working fully outsourced to and based at the offices of our global pharmaceutical 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.

    Responsibilities

    • With full ownership of investigator sites for your assigned studies, your 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, you will foster effective relationships with investigator site staff to ensure that key clinical metrics are met.
    • This will involve establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. You may also design and deliver training to site staff, when appropriate.
    • Typical duties 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 your site. You will ensure the integrity of clinical data through your ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
    • Through your ability to operate as a key part of a global study team, you will play a fundamental role in our client’s drug development process.

    Qualifications

    • Tertiary qualification; life science, medical, paramedical, pharmaceutical related degree
    • Minimum 1 year monitoring experience. Preference is given to candidates with at least 2 years of global trial experience, working for global pharmaceutical company or global CRO
    • Demonstrated strong understanding of company’s systems and processes
    • Demonstrated proficiency in the monitoring and management of clinical trials

    If you want to expand your skills set and take on a new challenging role with the opportunity, please don’t hesitate to send your CV to liuserena@prahs.com


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