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    Cra Ii In Oncology - Sponsor Dedicated - Marseille Or Paris

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 18, 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

    Description:

    Clinical Research Associate II in Oncology - Sponsor Dedicated - Paris Area or Marseille

    Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization that accelerates customer success. We provide clinical, medical affairs, and commercial insights to help address modern market realities.

    Our Clinical Development model places the customer and patient at the heart of everything we do. We're committed to simplifying and streamlining processes to make Syneos Health easier to collaborate with and work for.

    Whether in a Functional Service Provider partnership or a Full-Service environment, you will work with passionate professionals, innovating together to help our customers meet their goals. We are driven to accelerate the delivery of therapies because we are passionate about changing lives.

    Join the 29,000 employees across 110 countries who already know: WORK HERE MATTERS EVERYWHERE

    Why Syneos Health? We are committed to developing our people through career progression, supportive line management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters authenticity, inclusivity, and well-being for all employees. By embracing diverse perspectives, we create a workplace where everyone belongs.

    Job Responsibilities:

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) while ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards. Assess site performance and recommend actions to improve outcomes, escalating serious issues when necessary.
    • Ensure informed consent is appropriately documented, and safeguard patient confidentiality. Monitor for factors that may affect safety and data integrity, including protocol deviations and pharmacovigilance issues.
    • Review clinical data for accuracy and completeness, apply query resolution techniques, and guide site staff through the resolution process.
    • Verify investigational product (IP) inventory, administration, and compliance with protocol requirements, ensuring proper labeling and storage.
    • Maintain accurate records of site activities, ensuring Investigator Site File (ISF) completeness and compliance with regulatory standards.
    • Manage site activities and communication to ensure the timely achievement of project objectives and deliverables.
    • Support recruitment and retention strategies, track progress using project management tools, and communicate updates with stakeholders.
    • Attend Investigator Meetings, project staff meetings, and clinical training as required.
    • Maintain audit readiness and assist in audit preparations and follow-ups.
    • Ensure compliance with ICH/GCP guidelines, relevant regulations, and SOPs.

    Qualifications:

    • Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.
    • In-depth knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% regularly.

    Get to Know Syneos Health: Syneos Health has collaborated on 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and managed over 200 studies across 73,000 sites and 675,000+ trial patients over the past 5 years.

    Additional Information: This job description may be amended to include additional duties and responsibilities as needed. Qualifications may vary based on equivalent experience, skills, or education. Nothing in this description is intended to create an employment contract. We are committed to complying with the Americans with Disabilities Act and providing reasonable accommodations when necessary.

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