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    Cra (Level Ii) - Nantes

    Thermo Fisher Scientific
    1+ years
    Not Disclosed
    Remote, USA
    10 Nov. 11, 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 (CRA)

    Location: Remote/Field-based
    Work Schedule: Full-Time

    About Thermo Fisher Scientific:

    At Thermo Fisher Scientific, we are committed to delivering life-changing therapies that improve health outcomes for individuals and communities across the globe. Our teams are provided with the resources needed to achieve personal career goals while advancing scientific discovery and research. Through our global clinical trials network, spanning 100+ countries, and our PPD clinical research portfolio, we are driving innovation across laboratory, digital, and decentralized clinical trial services.

    We empower our teams to make a lasting impact by developing and delivering solutions that improve the health, safety, and well-being of people worldwide.

    Our Accolades Reflect Our Mission:

    • Recognized in the 2023 CRO Leadership Awards for patient access, data management, recruitment, and customer service.
    • Named “Best Lab” at the 2023 Vaccine Industry Excellence (ViE) Awards.
    • Awarded the 2023 APEX Award for employee development programs.
    • Recognized by ISG for leadership in digital services.

    Learn more about our success by visiting PPD.com.

    Your Role:

    As a Clinical Research Associate (CRA), you will be responsible for performing and coordinating clinical monitoring and site management processes in compliance with approved protocols and regulatory guidelines.

    Key Responsibilities:

    • Clinical Monitoring: Conduct remote or on-site visits to ensure that trials are conducted in compliance with the protocol, ICH-GCP guidelines, and applicable regulations.
    • Site Management: Develop and maintain strong relationships with investigational sites and oversee compliance with study procedures, ensuring subjects' rights and well-being.
    • Documentation & Reporting: Handle required documentation to maintain protocol compliance and ensure audit/inspection readiness.
    • Collaboration: Work closely with the sponsor, site personnel, and the clinical team to manage risk-based monitoring and project timelines.
    • Training & Support: Provide guidance and support to site personnel and study teams to ensure the trial is executed smoothly.

    Your Qualifications:

    • Education: Bachelor’s degree in a life sciences field, Registered Nursing certification, or equivalent experience.
    • Experience: At least 1 year of clinical monitoring experience, with demonstrated application of ICH GCP guidelines.
    • Languages: Fluent in French and English, with excellent communication skills to engage with medical staff and colleagues.
    • Skills: Strong attention to detail, time management, and the ability to handle Risk-Based Monitoring concepts. Proficient in Microsoft Office and other software applications.
    • Travel: Ability to travel and perform on-site visits (approximately 8 days per month).
    • Licenses: Valid driver’s license required.

    What We Offer:

    • Competitive Pay & Benefits: Competitive compensation and comprehensive benefits package.
    • Career Growth: Opportunities for professional development and career progression within Thermo Fisher Scientific.
    • Inclusive Work Culture: Join a company that values integrity, intensity, innovation, and involvement.

    Thermo Fisher Scientific is proud to be an EEO/Affirmative Action Employer, committed to creating a diverse and inclusive workplace where individuals of all backgrounds and experiences can thrive.

    Accessibility for Applicants with Disabilities:
    If you require assistance with the application process due to a disability, please contact us at 1-855-471-2255.

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