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    Clinical Research Associate - new delhi, India - Fortrea

    Fortrea
    Fortrea new delhi, India

    6 days ago

    Default job background
    Full time
    Description

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

    Summary of Responsibilities:

    Site management responsibility for clinical studies according to Fortrea's Standard
    Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor
    requirements, including verification of study training records.

    • Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard
    Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation,
    Process Monitoring, Routine Monitoring, and Close-out Visits.

    • Prepares and implements project plans related to Clinical Monitoring responsibilities.

    • Ensures the protection of subjects by verifying that informed consent procedures and
    protocol requirements are adhered to alongside applicable regulatory requirements.

    • Safeguards data integrity by careful source document review, source document verification,
    query generation, and resolution against established data review guidelines on Fortrea or
    client data management systems.

    • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are
    complete and current throughout the duration of the trial.

    • Guarantees that the study Investigational Product inventory and accountability is accurate
    and that study materials are stored securely and per protocol requirements.

    • Ensures adherence to global quality control and CRA performance metrics.

    • Ensures audit readiness at site level.

    • Acts in the project role of a Lead CRA as assigned.

    Qualifications (Minimum Required):

    • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

    • Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements

    Experience (Minimum Required):

    • A minimum of 2 years of Clinical Monitoring experience.

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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