Clinical Research Associate - Boston - Vivid Resourcing

    Vivid Resourcing
    Vivid Resourcing Boston

    2 days ago

    Description

    Job Title: Clinical Research Associate (CRA) – Oncology

    Location: Boston, MA (Hybrid or Remote, with travel)

    Reports to: Director of Clinical Operations

    Our client is a Boston-based biotechnology company dedicated to developing innovative oncology therapies that address unmet medical needs. The team is driven by scientific rigor, patient-centricity, and collaboration to advance cutting-edge cancer treatments from early development through late-stage clinical trials.

    Position Summary

    The Clinical Research Associate (CRA) will support the planning, execution, and monitoring of oncology clinical trials in compliance with ICH-GCP, FDA regulations, and company SOPs. The CRA will serve as a key liaison between investigative sites and the clinical operations team, ensuring data integrity, patient safety, and operational excellence across assigned studies.

    Key Responsibilities

    • Conduct site qualification, initiation, monitoring, and close-out visits for oncology clinical trials
    • Ensure protocol compliance, data accuracy, informed consent integrity, and patient safety
    • Monitor AE/SAE reporting, protocol deviations, and essential documentation
    • Train and support site staff and maintain strong site relationships
    • Review and maintain study documentation and Trial Master File (TMF)
    • Track site performance, identify risks, and proactively resolve issues
    • Collaborate cross-functionally and provide timely monitoring reports
    • Support audit and inspection readiness

    Qualifications

    • Bachelor's degree/Master's degree in Life Sciences, Nursing, or a related field (required)
    • 2+ years of CRA experience in clinical research (oncology preferred)
    • Experience monitoring interventional clinical trials (Phase I–III preferred)
    • Knowledge of Good Clinical Practices (GCP), clinical monitoring, study site oversight and management.
    • Strong knowledge of ICH-GCP and FDA regulations
    • Excellent communication, organizational, and problem-solving skills
    • Ability to manage multiple sites and travel up to 30%

    Offer

    • Salary k (depending on level of experience)
    • Career development opportunities in a growing oncology-focused organization
    • Collaborative, mission-driven work environment in the Boston biotech hub

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