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    Freelance Cra

    Al Solution
    5+ years
    Not Disclosed
    Boston
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Part Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Freelance Clinical Research Associate (CRA)
    Location: USA (East Coast preferred)
    Duration: 12 months
    Hours per week: 20 hours (0.5 FTE)
    Rate: Flexible, depending on experience
    Date needed: ASAP
    Interview Process: 2 stages

    Position Summary:

    A global radiopharmaceutical company is seeking a Freelance Clinical Research Associate (CRA) to oversee 4 clinics across the US. The role involves monitoring and managing clinical trials, ensuring compliance with regulatory requirements, and maintaining high standards of data integrity and patient safety.

    Key Responsibilities:

    • Monitor Clinical Trials: Ensure compliance with study protocols, regulatory requirements, and GCP guidelines.
    • Site Visits: Conduct pre-study, initiation, monitoring, and close-out visits at study sites.
    • Data Review: Review and verify case report forms (CRFs) and source documents for accuracy and completeness.
    • Adverse Events Reporting: Ensure timely and accurate reporting of adverse events and protocol deviations.
    • Training & Support: Provide training and support to site staff on study protocols, procedures, and regulatory requirements.
    • Documentation: Assist in the preparation and review of study-related documentation, including informed consent forms and monitoring plans.
    • Communication: Maintain effective communication with study sites, investigators, and stakeholders.
    • Study Updates: Participate in study team meetings and provide regular updates on site status and study progress.

    Requirements & Education:

    • Experience: Minimum 5+ years of experience as a CRA within the Biotech, Pharma, or CRO setting.
    • Education: Bachelor’s degree in a related field (e.g., life sciences, nursing, pharmacy).
    • Travel: Comfortable with up to 70% travel (1-2 days per week).
    • Valid Driver’s License: Required.
    • Skills:
      • Strong understanding of clinical trial processes and regulatory requirements.
      • Excellent organizational and time management skills.
      • Strong communication and interpersonal skills.
      • Ability to work independently and as part of a team.

    Why Apply?

    • Flexible role with 0.5 FTE commitment (20 hours/week).
    • Opportunity to work with a global radiopharmaceutical company in an impactful role.
    • Travel-based role with minimal on-site presence, ideally suited for candidates based on the East Coast.

    How to Apply:
    For further details or to apply, please contact George Higginson, Senior Associate at AL Solutions:
    Email: george@alsolutions.co.uk

    Alternatively, visit the AL Solutions website for more vacancies.

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