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    Sr Cra I Barcelona. Experience In Neurology. Sponsor Dedicated.

    Syneos Health
    0-2 years
    Not Disclosed
    Madrid
    10 Nov. 23, 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 I - Syneos Health®

    Company Overview: Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our work centers around translating clinical, medical affairs, and commercial insights into outcomes that address current market needs. With a commitment to innovation, we focus on simplifying processes and improving experiences for both our customers and employees.

    As a global leader with over 29,000 employees across 110 countries, we are driven to deliver impactful therapies that change lives. Our Total Self culture promotes authenticity, diversity, and inclusion, ensuring that everyone feels like they belong.

    Why Syneos Health?

    We prioritize the development of our people through career progression, continuous training, peer recognition, and a competitive rewards program. Our inclusive culture brings together diverse perspectives and backgrounds, enabling innovation and creating a workplace where you can authentically be yourself. At Syneos Health, we are building the company we want to work for and one our customers want to work with.

    Key Responsibilities:

    1. Site Management and Monitoring:

      • Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards such as ICH-GCP and GPP.
      • Use experience and judgment to assess site performance and provide recommendations, escalating serious issues as needed.
      • Ensure informed consent processes are followed and confidentiality is maintained.

    2. Clinical Data and Documentation:

      • Perform Source Document Reviews to verify the accuracy and completeness of clinical data.
      • Resolve queries and guide site staff on data entry, ensuring proper documentation and compliance with study protocols.
      • Oversee compliance with electronic data capture requirements.

    3. Investigational Product (IP) Management:

      • Verify IP inventory, reconciliation, storage, security, and distribution according to protocol.
      • Ensure investigational product labeling, importation, and return processes comply with GCP and local regulations.

    4. Regulatory and Archiving:

      • Regularly review the Investigator Site File (ISF) and ensure essential documents are archived according to local regulations.
      • Reconcile ISF with the Trial Master File (TMF) to ensure accuracy and compliance.

    5. Monitoring and Reporting:

      • Document site activities via confirmation letters, trip reports, and communication logs as per SOPs.
      • Track project status and manage site-level activities to ensure timelines and objectives are met.
      • Support patient recruitment, retention, and awareness strategies.

    6. Collaboration and Training:

      • Act as a primary liaison between site personnel and the project team.
      • Attend and prepare for Investigator and sponsor meetings.
      • Provide training and mentorship to junior CRAs and assist in sign-offs.

    7. Audit Readiness and Site Support:

      • Maintain audit readiness and ensure compliance with site and project audit standards.
      • Support preparation and follow-up for audits and ensure corrective actions are taken as necessary.

    8. Real World Late Phase (RWLP) Responsibilities:

      • Support site activities throughout the study lifecycle, including site identification and data collection.
      • Identify operational efficiencies and suggest process improvements based on local treatment patterns.
      • Collaborate with regulatory teams and ensure updated regulatory information is shared.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
    • Experience: Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements. Previous clinical research experience preferred.
    • Skills:
      • Proficiency with technology and data systems.
      • Strong communication, presentation, and interpersonal skills.
      • Critical thinking and problem-solving capabilities.
      • Ability to manage travel of up to 75% regularly.

    Why Work at Syneos Health?

    At Syneos Health, we offer an environment where your work matters. With a strong commitment to your personal and professional growth, our supportive culture ensures you thrive. Join our team and be part of a company that values inclusion, innovation, and making a lasting impact in healthcare.

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