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    Bilingual French Cra

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    3+ years
    Not Disclosed
    Remote, USA
    10 Nov. 11, 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 Title: Clinical Research Associate (CRA)

    Location: Multiple Locations (Travel Required)
    Company: ICON

    Company Overview:

    ICON is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. We work across the globe to help our clients in the pharmaceutical, biotechnology, and medical device industries develop and deliver life-changing treatments. We are committed to building a diverse and talented workforce to drive innovation and improve patient outcomes worldwide.

    Position Overview:

    As a Clinical Research Associate (CRA) at ICON, you will play a crucial role in ensuring the compliance and integrity of clinical trials from start-up through to completion. This involves overseeing study sites, ensuring adherence to ICH-GCP and regulatory guidelines, and working closely with site staff to ensure smooth execution of clinical studies. The role also involves managing site-specific actions, addressing any challenges, and driving performance improvements.

    What You Will Be Doing:

    • Regulatory & Protocol Compliance: Ensure adherence to ICH-GCP guidelines, protocol, and regulatory requirements. Evaluate site performance and provide actionable recommendations. Escalate significant issues promptly to the project team and develop corrective action plans.
    • Informed Consent & Patient Safety: Verify the informed consent process is properly conducted and documented, maintaining patient confidentiality. Assess site-specific risks and ensure clinical data integrity is preserved.
    • Monitoring Activities: Conduct monitoring using both on-site and remote methods as required, ensuring that study activities align with Clinical Monitoring Plans (CMP/SMP). Perform Source Document Review and Source Data Verification, ensuring clinical data accuracy.
    • Investigational Product (IP) Management: Oversee the management, storage, dispensing, and accountability of the investigational product (IP), ensuring compliance with protocol and regulatory requirements.
    • Data Review & Query Resolution: Monitor the entry and quality of clinical data, addressing discrepancies and ensuring timely resolution of queries in collaboration with site staff.
    • Site Documentation: Ensure accurate tracking of site activities, including site logs, patient enrollment, and investigational product accountability.
    • Collaboration & Communication: Work closely with Site Managers and other stakeholders to ensure that all site-level activities and communications are aligned with project timelines and deliverables.
    • Training & Audit Preparation: Provide guidance on audit readiness standards and assist in preparing for audits, ensuring appropriate follow-up actions are implemented.
    • Travel & Site Interaction: Manage up to 75% travel to study sites as required to support monitoring activities, provide training, and build relationships with site staff and stakeholders.

    What You Need to Succeed:

    • Education & Experience:

      • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
      • 3+ years of experience as a CRA with demonstrated experience in clinical monitoring (virtual or on-site).

    • Technical Competencies:

      • Solid understanding of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.
      • Experience with clinical trial management systems (CTMS) such as Siebel, eTMF, eISF (Florence), or similar platforms.
      • Strong computer skills and the ability to adapt to new technologies.
      • Excellent communication, presentation, and interpersonal skills.
      • Ability to travel up to 75% regularly.

    • Behavioral Competencies:

      • Strong problem-solving skills, with the ability to overcome barriers when implementing new processes and systems.
      • Demonstrated ability to build effective relationships with investigator site staff and other stakeholders.
      • Strong organizational, time management, and multitasking skills.
      • Excellent verbal and written communication skills, with the ability to interact effectively with internal and external stakeholders.

    What ICON Can Offer You:

    At ICON, we are committed to the success of our employees and the patients we serve. In addition to a competitive salary, we offer a comprehensive benefits package, including:

    • Health Insurance: A range of health insurance options to suit you and your family’s needs.
    • Retirement Planning: Competitive retirement planning offerings to maximize savings.
    • Employee Assistance Program (EAP): Access to a global network of professionals to support you and your family’s well-being.
    • Work-Life Balance: Flexible work options and generous annual leave entitlements.
    • Additional Benefits: Life assurance, childcare vouchers, gym memberships, and more.

    Why ICON?

    ICON is dedicated to fostering a culture of diversity, inclusion, and belonging. Our success depends on the diversity of our people, and we are proud to be an equal opportunity employer. We provide a workplace free of discrimination and harassment, and we encourage applicants from all backgrounds to apply.

    For more information, visit ICON Careers.

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