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    Clinical Research Associate Ii

    Icon
    2+ years
    Not Disclosed
    Romania
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote Education: B.A./B.S. 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

    Position: Clinical Research Associate 2 (CRA 2)
    Location: Bucharest, Romania (Flexible Hybrid Role)

    Join ICON plc, the world’s largest and most comprehensive clinical research organization, and advance your career in a sponsor-dedicated role that empowers you to impact global healthcare development.

    Key Responsibilities

    As a CRA 2, you will be responsible for managing clinical study sites and ensuring compliance with regulatory and sponsor requirements throughout the clinical trial process:

    • Site Relationship Management:

      • Build and maintain strong relationships with investigative sites across all trial phases.
      • Serve as the key point of contact for site staff on study-related matters.

    • Monitoring Activities:

      • Conduct on-site and remote monitoring visits, including validation, initiation, monitoring, and close-out visits.
      • Document clear, comprehensive, and timely visit reports.

    • Regulatory Compliance:

      • Ensure study activities comply with ICH-GCP, Sponsor SOPs, local regulations, protocols, and associated documents.
      • Collect, review, and monitor regulatory documentation throughout study phases.

    • Performance and Quality Oversight:

      • Address and resolve site performance and compliance issues.
      • Conduct root cause analysis and implement corrective/preventative measures.

    • Collaboration and Knowledge Sharing:

      • Work with cross-functional teams such as operations, regulatory affairs, and pharmacovigilance.
      • Act as a Subject Matter Expert (SME), mentor, or buddy to junior CRAs.

    • Audit Support:

      • Assist or lead preparation and participation in audit/inspection activities.
      • Perform co-monitoring visits when required.

    Qualifications and Skills

    • Education:

      • Bachelor’s degree in science, biology, or a related field (preferred).

    • Experience:

      • At least 2 years of direct site monitoring experience within a pharmaceutical, biotechnology, or CRO environment.

    • Core Competencies:

      • Strong knowledge of Good Documentation Practices (GDP).
      • Proven skills in site management, including recruitment and retention strategies.
      • Analytical mindset with the ability to understand and interpret data/metrics.
      • Proficiency in IT tools and clinical trial systems (CTMS, eTMF, etc.).

    • Personal Attributes:

      • Solution-oriented approach to complex challenges.
      • Effective communication and interpersonal skills.
      • Ability to manage multiple priorities and deliver high-quality results.

    Benefits of Working at ICON

    ICON is dedicated to nurturing talent and ensuring employee well-being:

    • Work-Life Balance:

      • Flexible working arrangements and generous annual leave entitlements.
      • Hybrid work setup with occasional on-site days.

    • Health and Wellness:

      • Comprehensive health insurance plans tailored to individual and family needs.
      • Global Employee Assistance Program (TELUS Health) for 24/7 support.

    • Financial Planning:

      • Competitive retirement plans to maximize long-term savings.
      • Life assurance and country-specific optional benefits like gym memberships and subsidized travel passes.

    • Professional Development:

      • A culture of continuous learning and career advancement.
      • Mentorship opportunities and exposure to diverse clinical research projects.

    Why Join ICON?

    ICON is committed to creating an inclusive, innovative, and empowering workplace where employees can thrive. As part of our Diversity, Inclusion, and Belonging initiatives, we welcome candidates from all backgrounds to contribute to our mission of advancing clinical development and improving global health.

    If you’re passionate about clinical research and ready to make an impact, we encourage you to apply today!

    Visit ICON Careers to learn more about this role and other exciting opportunities.

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