CRA/SCRA. Home based - bergamo - Pivotal

    Pivotal
    Pivotal bergamo

    1 settimana fa

    Descrizione

    Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence.

    Joining Pivotal as a CRA/SCRA means that you'll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You'll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

    Why Pivotal

    • We are passionate and fully committed with medical science while using technology, to make a positive impact
    • We provide an exceptional experience. We take care of our employees and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
    • We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

    Your responsibilities will include:

    • Be part of multi-national project teams and focus on delivering exemplary levels of customer service on multiple, challenging studies
    • Perform site selection, initiation, monitoring and close-out visits
    • Collaborate with the Regulatory team to obtain Ethic Committees (ECs) and Health Authorities (HAs) approvals in accordance with national/international regulations
    • Evaluate the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and local regulations. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
    • Manage site progress by tracking recruitment, eCRF completion, and data query resolution
    • Participate in problem-solving and risk-mitigation strategies
    • Collaborate with experts at study sites and with client representatives
    • Maintain a working knowledge of relevant regulations and company SOPs/processes
    • Demonstrate diligence in protecting the confidentiality of each subject/patient
    • Maintain study files in collaboration with our CTAs and eTMF specialists.

    Requirements:

    • University Degree in life science or other scientific discipline or apprenticeship in health care
    • Minimum of two years of on-site monitoring experience, alternatively an equivalent combination of education, training and experience
    • Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Flexibility to travel 6-8 visits per month

    Skills:

    • Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
    • Strong written and verbal communication skills, attention to detail and ability to work in a fast-pace environment
    • Ability to work autonomously
    • Fluency in Italian and English
    • Good knowledge of Office (Word, Excel and PowerPoint)

    What you can expect:

    • Resources that promote your career growth
    • Leaders that support flexible work schedules
    • Trainings to help you build your therapeutic knowledge
    • Dynamic work environments that expose you to new experiences

    Commitment to Equal Opportunity:

    At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.

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