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    Cra Ii In Oncology - Sponsor Dedicated - Marseille Or Paris

    Syneos Health
    2+ years
    Not Disclosed
    Paris
    10 Nov. 23, 2024
    Job Description
    Job Type: Remote Education: RN/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 II in Oncology

    Location: Sponsor-Dedicated – Paris Area or Marseille
    Company: Syneos Health

    About Syneos Health

    Syneos Health® is a global leader in fully integrated biopharmaceutical solutions, accelerating customer success through innovative clinical, medical, and commercial strategies.

    Our Clinical Development model focuses on bringing customers and patients to the forefront of everything we do, simplifying processes, and driving efficiency to deliver impactful outcomes.

    With 29,000 employees across 110 countries, we continuously strive to create a collaborative, innovative workplace to change lives.

    Why Join Syneos Health?

    • Career Development: Opportunities for training, growth, and progression.
    • Inclusive Culture: Total Self Culture promotes authenticity, diversity, and belonging.
    • Employee Support: Peer recognition programs, engaged management, and technical/therapeutic training.
    • Global Reach: Contribute to impactful work in a highly competitive and dynamic environment.

    Job Responsibilities

    Site Management & Monitoring

    • Perform site qualification, initiation, monitoring, and close-out visits (on-site or remotely).
    • Ensure compliance with ICH-GCP, regulatory guidelines, protocols, and company SOPs.
    • Evaluate site and staff performance, escalate critical issues, and develop corrective action plans.
    • Verify informed consent processes and safeguard subject confidentiality.

    Clinical Data Oversight

    • Conduct Source Document Review (SDR) and verify clinical data accuracy in case report forms (CRFs).
    • Resolve data queries remotely and on-site, guiding site staff to meet resolution timelines.
    • Ensure site compliance with electronic data capture (EDC) requirements.

    Investigational Product (IP) Management

    • Perform inventory, reconciliation, storage reviews, and security checks for investigational products.
    • Verify proper dispensing and administration according to the protocol, ensuring compliance with GCP/local regulations.

    Documentation & Compliance

    • Maintain and reconcile the Investigator Site File (ISF) and Trial Master File (TMF).
    • Document activities via reports, confirmation letters, and communication logs.
    • Support patient recruitment, retention, and engagement strategies.

    Collaboration & Audit Readiness

    • Act as the primary liaison with study site personnel and collaborate with the Central Monitoring Associate.
    • Prepare for Investigator Meetings, sponsor face-to-face meetings, and project-specific clinical training sessions.
    • Provide guidance to ensure audit readiness and assist in audit preparation.

    Real-World Late Phase (RWLP) Studies

    • Offer site support throughout the study lifecycle, from initiation to close-out.
    • Collaborate with local Sponsor affiliates, medical science liaisons, and healthcare professionals.
    • Conduct chart abstraction and data collection activities.
    • Proactively suggest potential sites based on local expertise and treatment patterns.

    Qualifications

    Education & Experience

    • 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.

    Skills & Competencies

    • Strong computer proficiency and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% regularly.

    About Syneos Health’s Impact

    • Supported 94% of FDA-approved drugs and 95% of EMA-authorized products in the last 5 years.
    • Conducted over 200 studies at 73,000 sites, engaging 675,000+ trial participants.

    Syneos Health continues to challenge the status quo and deliver meaningful solutions in an ever-changing global landscape.

    Additional Information

    • Responsibilities may vary based on business needs, and equivalent experience/skills will be considered.
    • Committed to compliance with local regulations, including the EU Equality Directive and ADA.
    • Reasonable accommodations are provided for employees/applicants to perform essential job functions.

    Learn more at Syneos Health.

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