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    Clinical Research Associate - Hyderabad, India - Lifelancer

    Lifelancer
    Lifelancer Hyderabad, India

    6 days ago

    Default job background
    Full time
    Description

    Job Summary:

    We are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The CRA will play a critical role in ensuring the successful planning, execution, and monitoring of clinical trials. The ideal candidate will have a strong understanding of clinical trial processes, regulatory requirements, and excellent communication and organizational skills.

    Key Responsibilities:

    Site Management:

    Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. Build and maintain strong relationships with investigative sites, investigators, and study coordinators.

    Clinical Trial Monitoring:

    Perform routine monitoring visits to assess site performance, data integrity, and regulatory compliance. Ensure timely resolution of data queries and issues identified during monitoring visits.

    Protocol Compliance:

    Ensure that all study activities are conducted in accordance with the approved protocol, SOPs, and applicable regulatory guidelines. Collaborate with investigators to address and resolve protocol-related queries.

    Regulatory Compliance:

    Assist in the preparation and submission of regulatory documents to ethics committees and regulatory authorities. Stay informed about changes in regulatory requirements and update study teams accordingly.

    Data Management:

    Collaborate with data management teams to ensure accurate and timely data collection and entry.

    Perform source data verification and data validation activities.

    Safety Reporting:

    Monitor and report adverse events in compliance with regulatory requirements and safety reporting procedures. Ensure that safety reports are submitted to relevant authorities and stakeholders.

    Training and Support:

    Provide training and support to site staff on study protocols, data collection, and regulatory compliance. Act as a resource for investigators and site staff throughout the duration of the study.

    Requirements:

    Education: Bachelor's degree in a relevant life sciences field.

    Experience:

    Minimum of 3 years of experience as a Clinical Research Associate.

    Proven track record of successful site management and monitoring in clinical trials.

    Regulatory Knowledge: Familiarity with regulatory requirements and guidelines governing clinical trials.

    Please use the below link for job application and quicker response.

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