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    Sr Cra Ii In Neurology - Sponsor Dedicated - Home Based France

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 20, 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

    Senior Clinical Research Associate in Neurology - Sponsor Dedicated - Home-Based, France

    Location: Home-Based, France

    Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical, and commercial insights into impactful outcomes. With our Clinical Development model, we place the customer and patient at the center of everything we do, continually striving to simplify and streamline our processes. As part of our team, you will help drive innovation and deliver therapies that change lives.

    Job Responsibilities:

    • Site Management & Monitoring: Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote), ensuring compliance with regulatory standards, ICH-GCP, GPP, and study protocols. Use professional judgment to evaluate site performance and escalate serious issues as necessary, developing corrective action plans.
    • Informed Consent & Patient Safety: Verify that the informed consent process is properly executed and documented. Safeguard patient confidentiality while assessing factors that might affect patient safety and clinical data integrity, such as protocol deviations or pharmacovigilance issues.
    • Data Review & Compliance: Conduct Source Document Review and verify the accuracy of data entered into case report forms (CRFs) by reviewing medical records and site documentation. Resolve data queries and ensure the site complies with electronic data capture requirements.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, storage, and security. Ensure that IP is dispensed and administered as per the protocol, addressing issues related to blinded or randomized information.
    • Documentation & Reporting: Review the Investigator Site File (ISF) for completeness and reconcile it with the Trial Master File (TMF). Ensure the site follows document archiving procedures in compliance with local regulations. Document site activities and project updates through confirmation letters, follow-up letters, trip reports, and communication logs.
    • Project Coordination: Manage site-level activities to ensure that project timelines, objectives, and budgets are met. Quickly adapt to changing priorities to maintain project progress.
    • Training & Mentorship: Provide training and mentorship to junior CRAs, ensuring all site team members are trained and compliant with project requirements. Assist in training and sign-off visits for junior staff.
    • Audit & Compliance: Maintain readiness for audits and provide support during preparation and follow-up actions to ensure compliance.
    • Real World Late Phase (RWLP) Study Support: As part of the Senior CRA role, assist with site support throughout the study lifecycle, from site identification through close-out. Provide knowledge of local requirements for RWLP study designs, participate in chart abstraction, and contribute to data collection.
    • Collaboration: Build relationships with sponsors, medical science liaisons, and local country staff. Proactively suggest potential sites based on local knowledge of treatment patterns and health care provider networks.
    • Continuous Improvement: Identify operational efficiencies and process improvements, and collaborate with the RWLP regulatory team to ensure regulatory updates are applied.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
    • Experience: At least 2 years of experience as a Clinical Research Associate, with a solid understanding of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
    • Skills: Strong computer proficiency and a willingness to adopt new technologies. Excellent communication, presentation, and interpersonal skills, with basic critical thinking abilities.
    • Travel: Ability to manage required travel of up to 75% regularly.

    Why Syneos Health?

    Syneos Health is committed to developing our people through career progression, technical training, and a supportive work environment. We foster a Total Self culture where employees can be their authentic selves, and diversity is celebrated. Join our team and contribute to our mission to accelerate therapies and change lives.

    Apply Today and be a part of a globally diverse team driving healthcare innovation.

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