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    Clinical Research Associate Ii

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    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 21, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Title: Clinical Research Associate 2
    Company: ICON
    Location: Romania (Hybrid - Occasionally on-site in Bucharest)

    About ICON:
    ICON is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. We partner with healthcare and biopharmaceutical companies to bring life-changing therapies to patients. ICON is dedicated to building a diverse, inclusive, and high-performance culture, rewarding talent and supporting work-life balance.

    What You Will Be Doing:

    As a Clinical Research Associate 2 (CRA 2), you will play a key role in managing and monitoring clinical trial sites, ensuring compliance with all regulatory requirements, and building strong relationships with site personnel throughout the trial phases. Your responsibilities include:

    • Site Management: Developing and maintaining strong relationships with study sites, ensuring all phases of the trial are executed effectively.
    • Monitoring & Oversight: Conducting remote and on-site monitoring visits (including validation, initiation, and close-out visits) to ensure compliance with ICH-GCP, Sponsor SOPs, and local regulations.
    • Documentation & Reporting: Collecting, reviewing, and maintaining required regulatory documentation. Documenting visits and interactions in CTMS and eTMF systems.
    • Issue Resolution: Identifying, assessing, and resolving any site performance or compliance issues, ensuring successful recruitment and retention of patients.
    • Collaboration: Working with country operations, finance, regulatory affairs, pharmacovigilance, and other stakeholders to support site performance.
    • Mentorship: Acting as a Subject Matter Expert (SME), mentoring junior CRAs and sharing best practices.
    • Audit Support: Leading or assisting in audit/inspection activities when needed.

    Requirements:

    • B.A./B.S. degree in science or biology (preferred).
    • At least 2 years of site monitoring experience in the bio/pharma/CRO industry.
    • Strong understanding of Good Documentation Practices and experience in site management, including performance management and recruitment.
    • Proficiency in IT systems and ability to analyze data to act appropriately.
    • Solution-oriented approach with the ability to handle complex issues, conduct root cause analysis, and implement corrective actions.

    What ICON Offers:

    ICON values the quality and dedication of its people. In addition to competitive salaries, we offer a range of benefits designed to enhance well-being and work-life balance, including:

    • Annual leave entitlements and health insurance options tailored to your needs.
    • Retirement planning and financial benefits.
    • Global Employee Assistance Programme with 24/7 access to over 80,000 professionals.
    • Life assurance, childcare vouchers, gym memberships, health assessments, and more.

    Why Join ICON?

    At ICON, we prioritize diversity and inclusion, fostering a workplace that supports innovation and creativity. Our diverse workforce is key to our success, enabling us to better serve our people, patients, customers, and communities.

    Interested in the role but unsure if you meet all the requirements? We encourage you to apply! We may have other opportunities that align with your experience.

    Apply Now: ICON Careers

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