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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 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

    Senior Clinical Research Associate - Neurology (Sponsor Dedicated) – Home Based, France

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We transform clinical, medical affairs, and commercial insights into outcomes that address the modern realities of the healthcare landscape.

    Our Clinical Development model places the customer and the patient at the center of everything we do. We are constantly exploring ways to simplify and streamline our processes, making Syneos Health easier to work with and making us a great place to work for our team members.

    Whether you join us in a Functional Service Provider partnership or in a Full-Service environment, you will collaborate with passionate, innovative problem-solvers 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.

    Why Syneos Health?

    We are committed to developing our people through career growth, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages authenticity, fostering a diverse and inclusive environment where every team member feels like they belong.

    Job Responsibilities:

    • Site Monitoring & Management:
      Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol. Use judgment and experience to evaluate site performance and escalate serious issues to the project team while developing action plans.
    • Informed Consent & Patient Safety:
      Verify informed consent processes are properly executed and documented. Safeguard patient confidentiality and assess factors affecting patient safety and data integrity at the investigator site.
    • Data Review & Compliance:
      Conduct Source Document Reviews to ensure the accuracy and completeness of data entered into case report forms (CRFs). Drive query resolution with site staff to closure within agreed timelines and ensure site compliance with electronic data capture systems.
    • Investigational Product (IP) Management:
      Manage IP inventory, reconcile, and ensure proper security, labeling, and administration according to the protocol. Monitor for risks associated with blinded or randomized IP data.
    • Documentation & Reporting:
      Track project activities, including follow-up letters, trip reports, and communication logs, ensuring accurate documentation in line with SOPs and the Clinical Monitoring/Site Management Plan.
    • Project Coordination:
      Manage site-level activities, ensuring project objectives and timelines are met. Adapt quickly to changes in project scope and priorities.
    • Liaison & Training:
      Serve as the primary liaison with site personnel. Ensure training and compliance are met across project sites. Attend and contribute to Investigator Meetings and other sponsor meetings.
    • Audit Readiness & Compliance:
      Ensure audit readiness and assist sites with preparation for audits and follow-up actions.
    • Mentorship & Leadership:
      Mentor and provide guidance to junior CRAs, including conducting training and sign-off visits for junior staff. Assist in leadership tasks under the supervision of an experienced Clinical Operations Lead.
    • Real World Late Phase (RWLP) Responsibilities:
      Provide site support throughout the study lifecycle, from identification through close-out. Collaborate with sponsors, affiliates, and medical science liaisons to improve site operations and patient recruitment.
      • Develop country-specific informed consent forms and collaborate with the RWLP Regulatory team to ensure updated regulatory information is applied.
      • Participate in bid defense meetings and proactively identify operational efficiencies.

    Qualifications:

    • Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
    • Experience: Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
    • Skills: Proficient computer skills and ability to embrace new technologies. Excellent communication, presentation, and interpersonal skills. Basic critical thinking skills are expected.
    • Travel: Willingness to travel up to 75% regularly.

    About Syneos Health

    Over the last five years, Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites and involving over 675,000 trial patients.

    At Syneos Health, you’ll drive change and contribute to delivering therapies faster, helping patients around the world. If you’re ready to make a difference in the clinical development world, join us.

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