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    Clinical Research Associate Ii

    Icon
    2+ years
    Not Disclosed
    Romania
    10 Nov. 23, 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

    Job Title: Clinical Research Associate 2

    Location: Bucharest, Romania (Sponsor Dedicated Role)
    Company: ICON plc

    About ICON plc

    ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. ICON partners with global pharmaceutical, biotechnology, and medical device companies to advance clinical research and improve patient outcomes.

    Role Overview

    As a Clinical Research Associate 2 (CRA 2), you will join ICON’s Functional Service Provider (FSP) team, working on a sponsor-dedicated basis. This position involves occasional work at the sponsor's Bucharest office (approximately one day per week, subject to monitoring visits).

    Key Responsibilities

    Site Relationship Management:

    • Develop and maintain strong relationships with clinical sites throughout all trial phases.
    • Act as the primary point of contact for investigators and site staff regarding protocol conduct, recruitment, retention, and regulatory issues.

    Clinical Monitoring:

    • Conduct remote and on-site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, and Site Monitoring Plans.
    • Perform various site visits, including validation, initiation, monitoring, and close-out visits.
    • Prepare detailed and timely visit reports and contact records.

    Regulatory Compliance:

    • Manage and review regulatory documentation throughout the study lifecycle (start-up, maintenance, and close-out).
    • Support audit/inspection readiness and participate in audit/inspection activities as needed.

    Site Performance Oversight:

    • Identify, assess, and resolve site performance, quality, or compliance issues.
    • Perform root cause analysis and implement preventative and corrective actions.

    Team Contribution & Knowledge Sharing:

    • Act as a Subject Matter Expert (SME) to the CRA team, providing mentorship and sharing best practices.
    • Perform co-monitoring visits where required.

    Collaboration:

    • Partner with internal teams (operations, finance, regulatory affairs, pharmacovigilance, and legal) and external stakeholders (vendors, IRBs/IECs, and regulatory authorities).
    • Maintain and update data in systems such as CTMS and eTMF as per required timelines.

    Requirements

    Education & Experience:

    • Bachelor’s degree in science, biology, or a related field preferred.
    • Minimum of 2 years of direct site monitoring experience in bio/pharma or CRO settings.

    Skills & Competencies:

    • Strong knowledge of Good Documentation Practices and site management techniques.
    • Proficient in IT tools and systems, with the ability to manage data and metrics.
    • Excellent problem-solving skills, capable of managing complex issues in a solution-oriented manner.
    • Effective communication and collaboration abilities.

    Benefits of Working at ICON

    Compensation & Benefits:

    • Competitive salary with additional country-specific benefits.
    • Generous annual leave entitlements.
    • Flexible health insurance options for you and your family.
    • Retirement planning programs for long-term financial security.
    • Life assurance coverage.
    • Access to the Global Employee Assistance Programme (TELUS Health) for 24/7 well-being support.

    Optional Benefits (Country-Specific):

    • Childcare vouchers.
    • Bike purchase schemes.
    • Discounted gym memberships.
    • Subsidized travel passes.
    • Health assessments.

    Career Development:

    • Continuous learning culture with opportunities for professional development.

    Diversity & Inclusion:

    ICON is committed to fostering a diverse, inclusive, and accessible workplace. We value innovation driven by diverse perspectives and provide equal opportunities for all qualified applicants.

    How to Apply

    If you’re interested in this role but unsure if you meet all the requirements, we encourage you to apply. We welcome diverse talent and may find that you’re the perfect fit for this or other opportunities at ICON.

    Need accommodations? ICON is dedicated to providing support for candidates with medical conditions or disabilities. For assistance, please submit a request here.

    For more information about our benefits, visit our Careers Site.

    Current ICON Employees: Click here to apply.

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