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    Clinical Research Associate Ii

    Icon Strategic Solutions
    3+ years
    Not Disclosed
    Ambala
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time 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 Description: Clinical Research Associate 2

    Location: ICON Romania (Sponsor-Dedicated Role)

    Company Overview:

    ICON plc is the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence. ICON offers a dynamic environment where you can contribute to impactful clinical studies, develop your skills, and grow within the industry. ICON Romania is currently looking for experienced Clinical Research Associates (CRAs) to join their Field Services Provider (FSP) team for a sponsor-dedicated role. This position offers the flexibility of working remotely with occasional visits to the sponsor’s office in Bucharest, typically one day per week.

    Role Overview:

    As a Clinical Research Associate 2, you will play a pivotal role in the management and monitoring of clinical trials, ensuring compliance with ICH-GCP, local regulations, and sponsor requirements. You will develop strong relationships with study sites, oversee site performance, and contribute to the successful execution of clinical trials. This is a key role in ensuring high-quality site management and trial monitoring.

    Key Responsibilities:

    • Site Relationship Management:

      • Develop and maintain strong, positive relationships with investigators and site staff throughout the entire trial process.
      • Provide support during site initiation, monitoring visits, and close-out visits.

    • Clinical Trial Monitoring:

      • Perform remote and on-site monitoring activities in line with study protocols, regulatory guidelines, and sponsor procedures.
      • Conduct various site visits, including validation, initiation, monitoring, and close-out visits. Document visit findings in a clear, comprehensive, and timely manner.
      • Collect, review, and ensure the required regulatory documentation is in place for study start-up, maintenance, and close-out.

    • Compliance & Performance Management:

      • Ensure adherence to ICH-GCP, sponsor SOPs, local laws and regulations, and the study protocol.
      • Identify, assess, and resolve any site performance, quality, or compliance issues, and provide solutions where necessary.
      • Address recruitment and retention issues, manage protocol deviations, and ensure overall site performance.

    • Collaboration & Cross-Functional Support:

      • Work closely with country operations, regulatory affairs, pharmacovigilance, legal, and other functional teams to support site activities.
      • Collaborate externally with vendors, Institutional Review Boards (IRBs), Ethics Committees (IECs), and Regulatory Authorities.

    • Documentation & Reporting:

      • Maintain accurate and up-to-date information in systems such as CTMS and eTMF, adhering to project timelines.
      • Contribute to the CRA team's knowledge by acting as a process Subject Matter Expert (SME), mentoring colleagues, and sharing best practices.
      • Support audit and inspection activities as needed.

    Requirements:

    • Education:

      • A Bachelor’s degree (B.A./B.S.) in science, biology, or a related field.
      • 2+ years of direct site monitoring experience in the bio/pharma/CRO industry.

    • Skills & Experience:

      • Strong knowledge of Good Documentation Practices (GDP).
      • Proven experience in site management, including patient recruitment and site performance management.
      • Good IT skills and the ability to manage data/metrics analysis effectively.
      • Ability to resolve complex issues and perform root cause analysis, implementing preventative and corrective actions.
      • Solution-oriented approach with the ability to work independently and make informed decisions.

    Benefits of Working at ICON:

    ICON offers a comprehensive and competitive benefits package that focuses on the well-being and work-life balance of its employees, including:

    • Annual Leave: Generous vacation and leave entitlements.
    • Health Insurance: A range of health insurance offerings for you and your family.
    • Retirement Planning: Competitive retirement planning options to help you save and plan for the future.
    • Employee Assistance Program: TELUS Health provides 24-hour access to a global network of over 80,000 independent professionals to support you and your family’s well-being.
    • Life Assurance: Comprehensive life assurance coverage.
    • Flexible Benefits: Country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, health assessments, and subsidized travel passes.

    ICON is committed to creating an inclusive and diverse workplace where talent is nurtured, and employees are empowered to succeed.

    Interested?
    If you're passionate about clinical research and have the required experience, we encourage you to apply for this exciting opportunity with ICON. This role offers an opportunity to grow within the largest clinical research organization and contribute to life-changing healthcare advancements.

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