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    Clinical Project Assistant / Clinical Research Associate - Hybrid

    Infotree Global Solutions
    1-5 years
    Not Disclosed
    Santa Monica
    12 May 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title:

    Clinical Project Assistant / Clinical Research Associate

    Type:

    W2 Contract & Hybrid Role

    Location:

    Santa Monica, CA

    Job Description:

    Our leading pharmaceutical client is seeking a Clinical Project Assistant/Clinical Research Associate. This role involves providing administrative assistance in site selection, study implementation, and ongoing coordination of study sites, either directly or via Contract Research Organizations (CROs).

    Responsibilities:

    • Provide administrative assistance in site selection, study implementation, and ongoing coordination of study sites.
    • Monitor routine study sites, perform routine data collection, source data verification, and review regulatory documents/files in compliance with protocols, regulatory requirements, SOPs, and Monitoring Plan, as required.
    • Assist under supervision in the review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, and clinical study reports.

    Required Education & Experience:

    • Familiarity with Microsoft Word, PowerPoint, and Excel.
    • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
    • Ability to contribute to SOP development.
    • Excellent verbal, written, interpersonal, and presentation skills.

    Additional Requirements:

    • Work authorization for the United States.
    • 1+ years of work experience with Microsoft PowerPoint.
    • 1+ years of work experience with Microsoft Excel.

    Application:

    If you are a suitable candidate, please apply quickly!

    Note: This position does not support C2C or H1B candidates.

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