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    Cra Ii In Oncology - Sponsor Dedicated

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe
    10 Oct. 24, 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

    Clinical Research Associate II in Oncology - Sponsor Dedicated - Paris Area (Home Based)

    Slug: clinical-research-associate-oncology-paris

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

    Our Clinical Development model centers on the customer and the patient. We continuously seek ways to simplify and streamline our work, making Syneos Health easier to collaborate with and a great place to work.

    Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

    Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health?

    We are passionate about developing our people through career development, supportive line management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture allows you to authentically be yourself, fostering a global community where diversity of thought and background is celebrated.

    Job Responsibilities

    • Perform site qualification, initiation, monitoring, management, and close-out visits (on-site or remote) to ensure compliance with regulatory, ICH-GCP, and protocol standards.
    • Evaluate overall site performance and communicate/escalate issues promptly, developing action plans as needed.
    • Verify informed consent processes and protect patient confidentiality, assessing factors affecting patient safety and data integrity.
    • Conduct Source Document Review and verify clinical data accuracy in case report forms (CRFs).
    • Manage investigational product (IP) inventory and ensure proper protocol adherence for dispensing and administration.
    • Review the Investigator Site File (ISF) for accuracy and completeness, ensuring compliance with local guidelines.
    • Document activities through confirmation letters, reports, and tracking systems to monitor progress and resolve action items.
    • Manage site-level communications and activities to meet project objectives, budgets, and timelines.
    • Act as a primary liaison with study site personnel and ensure compliance with training requirements.
    • Prepare for and attend Investigator Meetings, global monitoring meetings, and training sessions.
    • Provide guidance towards audit readiness standards and support necessary follow-up actions.
    • For Real World Late Phase studies, perform additional site support tasks and chart abstraction activities.

    Qualifications

    What We’re Looking For:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
    • Strong computer skills and ability to adapt to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% regularly.

    Get to Know Syneos Health

    In the past five years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with more than 675,000 trial patients.

    Join us in challenging the status quo and taking initiative in a competitive and dynamic environment.

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