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    Clinical Research Associate, Sponsor Dedicated

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    0 -1 yrs. in PV / 1-2 yrs. in clinical practice years
    Preffered by Company
    Frankfurt
    Not Disclosed May 28, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, 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 Research Associate (Sponsor Dedicated)

    Location: Germany (Remote)

    Reference ID: 2024-108091

    Department: Clinical Monitoring, ICON Strategic Solutions

    Application Contact: Sarah Cameron

    Role Overview: The Clinical Research Associate (CRA) will be integral in conducting Phase I-IV clinical studies, primarily serving as the main point of contact for the site. Responsibilities include executing monitoring plans, ensuring site GCP compliance, writing trip reports, resolving site issues, and managing site activities in accordance with regulatory guidelines and SOPs.

    Key Responsibilities:

    • Conduct comprehensive site management activities, including qualification, initiation, training, routine monitoring, and close-out visits.
    • Develop and implement recruitment strategies and monitor site safety.
    • Ensure adherence to internal policies, SOPs, and regulatory guidelines.
    • Assist with study start-up activities, including protocol and CRF review, site selection, and feasibility assessments.
    • Manage investigator meeting activities and site communication to maintain strong relationships.
    • Write detailed visit reports and follow-up letters within specified timelines.
    • Coordinate the shipment of clinical supplies and study drugs in collaboration with regional CRAs.
    • Maintain accurate site tracking records and manage drug safety issues promptly.
    • Assist with data query resolution and perform in-house review of Case Report Forms.

    Requirements:

    • At least 1.5 years of independent CRA experience, including monitoring visits, from a pharmaceutical company or CRO.
    • Fluent in German and English, with excellent communication skills.
    • Educational background in life sciences or licensed healthcare professional.
    • Proficient knowledge of ICH-GCP guidelines and both local and international regulatory requirements.

    Why ICON? ICON offers a comprehensive and competitive total rewards package, including a variety of variable pay and recognition programs. We provide extensive benefits designed to support you and your family at all stages of your career. ICON is committed to a continuous learning culture that challenges and engages you in meaningful work. As an equal opportunity and inclusive employer, ICON actively seeks to create a workplace free from discrimination and harassment.

    Additional Information: Applicants needing reasonable accommodations for any part of the application process due to a medical condition or disability should contact us. We encourage individuals who may not meet every single requirement to apply, as they may still be perfect for the role or other opportunities within ICON.

    Application Process: Interested candidates are encouraged to apply directly and connect with Sarah Cameron for any inquiries or further information.

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