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    Clinical Research Associate Ii

    Al Solution
    2+ years
    Not Disclosed
    Remote, USA
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    Company Overview:
    AL Solutions is partnering with a growing biotech firm that emphasizes quality, innovation, and patient safety. Our client is dedicated to driving excellence in clinical research and delivering impactful advancements in the field.

    Position Summary:
    We are seeking a dedicated and experienced Clinical Research Associate II (CRA II) to join our team. In this role, you will oversee and monitor clinical trials across various investigational sites, ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.

    Responsibilities:

    • Conduct site initiation, interim monitoring, and close-out visits to ensure adherence to study protocols and high-quality data collection.
    • Perform source document verification, query resolution, and data review at study sites.
    • Ensure the accurate and timely completion of monitoring reports, study documentation, and regulatory filings.
    • Develop and maintain strong relationships with investigators, site personnel, and study teams.
    • Identify and address site-related issues or challenges that may impact study conduct or data integrity.
    • Assist in the selection and qualification of investigational sites, ensuring they meet study requirements and have adequate resources.
    • Collaborate with the Data Management team to ensure accurate and timely data collection and reporting.
    • Stay updated with relevant industry guidelines, regulations, and best practices.

    Requirements:

    • Education & Experience:

      • Bachelor’s degree in a scientific or healthcare-related discipline.
      • Minimum of 2 years of experience as a Clinical Research Associate, preferably within a CRO or pharmaceutical setting.

    • Skills & Competencies:

      • Strong understanding of ICH-GCP guidelines and regulatory requirements.
      • Proven experience in site monitoring, including site initiation, interim monitoring, and close-out visits.
      • Excellent communication and interpersonal skills, with the ability to build and maintain effective relationships.
      • Detail-oriented and organized, with the capability to manage multiple tasks simultaneously.
      • Proficient in electronic data capture systems and clinical trial management systems.
      • Willingness to travel to investigational sites as needed.

    Benefits:

    • Competitive Salary
    • 401(k) Plan
    • Additional benefits and perks

    Join us in advancing clinical research and improving patient outcomes with a leading biotech company. Apply today to become part of our dedicated team.

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