PRAHS

  • Clinical Research Associate

    Job Locations - | Czech Republic-Prague
    Posted Date 3 weeks ago(5/30/2018 11:02 AM)
    ID
    2018-47175
  • Overview

    Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

     

    As a Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a prestigious organization, specialising in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

    Responsibilities

    Your responsibilities: 

     

    Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation. The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site life cycle. Key responsibilities will include:

     

    • Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the sites right through to close-out, in accordance with the clinical monitoring plan
    • Manage submissions including the coordination of submissions packages to EC/RA, responding to EC queries
    • Manage confidentiality agreements with sites
    • Proactively identify and resolve any site challenges, and implement mitigation plans to any risks to study start-up, identifying trends and issues as needed
    • Developing effective relationships with investigator site staff to ensure that key clinical metrics are met
    • Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.

     

    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.

    Qualifications

    You are:

     

    The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits and in study start-up activities from either a pharmaceutical company or a CRO environment.

     

    Prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential. Fluency in Czech and English language is an absolute requirement, as well as ability to communicate effectively with others and manage your time effectively.

     

    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.

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