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

    Syneos Health
    0-2 years
    Not Disclosed
    Barcelona
    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 fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market realities. Our Clinical Development model prioritizes the customer and the patient, aiming to simplify and streamline operations while delivering impactful solutions.

    With a global presence of over 29,000 employees across 110 countries, we are committed to driving change and delivering therapies that improve lives. Our Total Self culture promotes inclusion and authenticity, ensuring that everyone feels like they belong.

    Why Syneos Health?

    Syneos Health is dedicated to the career development and progression of its employees. Our supportive environment offers peer recognition, technical training, and competitive rewards. We foster an inclusive work culture, valuing diverse perspectives and backgrounds, ensuring our team members thrive personally and professionally.

    Join us to be part of a global organization where work here matters everywhere.

    Key Responsibilities:

    1. Site Management and Monitoring:

      • Perform site qualification, initiation, monitoring, and close-out visits (both on-site and remotely), ensuring compliance with regulatory standards such as ICH-GCP and Good Pharmacoepidemiology Practice (GPP).
      • Use judgment and experience to evaluate site performance, making recommendations and escalating issues when necessary.
      • Ensure proper informed consent procedures and confidentiality protection for patients.

    2. Clinical Data and Documentation:

      • Conduct Source Document Review and verify the accuracy and completeness of clinical data entered in the case report form (CRF).
      • Resolve data queries and guide site staff to ensure compliance with study protocols.
      • Ensure that the site complies with electronic data capture (EDC) requirements.

    3. Investigational Product (IP) Management:

      • Oversee the inventory, reconciliation, storage, and security of investigational products.
      • Verify that IP is dispensed and administered according to protocol and manage risks related to blinded or randomized information.

    4. Regulatory and Archiving:

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

    5. Monitoring Activities and Reporting:

      • Document site activities through trip reports, communication logs, and other project documents as per SOPs and clinical monitoring plans.
      • Support patient recruitment and retention strategies.
      • Ensure timely completion of assigned tasks and meet project objectives, timelines, and deliverables.

    6. Collaboration and Training:

      • Serve as the primary liaison between site personnel and the project team.
      • Participate in Investigator and Sponsor meetings.
      • Provide mentorship and training to junior CRAs and sign off on visits for them.

    7. Audit Readiness and Site Support:

      • Maintain audit readiness and support preparation for audits.
      • Act as a mentor for junior staff, providing guidance on audit standards and procedures.

    8. Real World Late Phase (RWLP) Responsibilities:

      • Support site activities throughout the study lifecycle, including site identification, chart abstraction, and data collection.
      • Work with sponsor affiliates and medical science liaisons to ensure the study meets regulatory and operational standards.
      • Identify potential sites and suggest improvements based on local knowledge of treatment patterns and healthcare provider associations.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Experience: Knowledge of Good Clinical Practice (GCP) and ICH Guidelines. Previous experience in clinical research or related fields preferred.
    • Skills:
      • Proficient in computer skills and technology adoption.
      • Strong communication, presentation, and interpersonal skills.
      • Basic critical thinking skills and problem-solving capabilities.
      • Ability to travel up to 75% as required.

    Why Work at Syneos Health?

    At Syneos Health, we’re passionate about creating a work environment where you can thrive. We provide ample opportunities for professional growth, collaboration, and innovation in the field of clinical research. Join our team and make an impact that matters.

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