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    Clinical Research Associate - Miami, United States - The Fountain Group LLC

    The Fountain Group LLC
    The Fountain Group LLC Miami, United States

    6 days ago

    The Fountain Group LLC background
    Description
    The Fountain Group are a national staffing firm and are currently seeking a Clinical Research Associate for a prominent Medical Device client of ours. This position is Remote. Details for the position are as follows:

    Job Description:
    • Pay: /hr.
    • Remote role.
    • 1 year assignment to start with potential for extension or conversion.
    • Responsible for supporting clinical activities to generate clinical evidence that will support product registration and/or product market clearance/approval.
    • This position is part of the Clinical Affairs Department for the Clinical Decision Support business unit and is fully remote.
    • Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
    • Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.
    • Onsite and/or remote monitoring of data and overseeing corrective actions.
    • Drive schedule deliverables to meet the overall study timelines.
    • Develop and drive centralized processes to optimize instrument device data, reconciliation of instrument data to sample list, identification of protocol deviations and data discrepancies to drive compliance to study protocol(s), applicable regulations, Good Clinical Practices (GCP) and Standard Operating Procedures.
    Nice to Have Experience:
    • Real-world data.
    • Cardiovascular clinical trials.
    • Electronic data capture (EDC) system (Medidata) and eTMF system (Florence).
    • Clinical research certification (i.e., SOCRA, CCRA, CCRC).
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