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    Cra Ii Madrid. Experience In Neurology. Sponsor Dedicated.

    Syneos Health
    0-2 years
    Not Disclosed
    Barcelona
    12 Nov. 23, 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, WHO DD Coding

    Clinical Research Associate II - Syneos Health®

    Company Overview: Syneos Health® is a leading integrated biopharmaceutical solutions organization that accelerates customer success by delivering clinical, medical affairs, and commercial insights to drive outcomes in today's rapidly evolving market. We bring patients and customers to the heart of everything we do, simplifying our processes to make Syneos Health a more efficient and enjoyable place to work.

    With over 29,000 employees across 110 countries, we are driven to change lives through the delivery of therapies. We’re committed to creating a diverse and inclusive environment where everyone belongs, collaborating as passionate problem-solvers to achieve customer goals.

    Why Syneos Health? At Syneos Health, we prioritize the development of our people, offering career progression, technical and therapeutic training, and a supportive and engaging work environment. Our Total Self culture fosters an inclusive environment where you can authentically be yourself, promoting personal and professional growth. Join us and be part of a company where work matters, everywhere.

    Key Responsibilities:

    1. Site Management and Monitoring:

      • Perform site qualification, initiation, interim monitoring, and close-out visits, either on-site or remotely, ensuring compliance with regulatory requirements, ICH-GCP, and study protocols.
      • Evaluate site performance and escalate any serious issues to the project team, offering actionable recommendations and solutions.
      • Ensure informed consent is obtained correctly and documented, while safeguarding patient confidentiality and ensuring safety.

    2. Clinical Data and Documentation:

      • Conduct Source Document Review (SDR) and verify the accuracy and completeness of clinical data in the case report form (CRF).
      • Resolve data queries, providing guidance to site staff as necessary, and ensuring timely query closure.
      • Verify compliance with electronic data capture (EDC) systems and ensure proper data handling.

    3. Investigational Product (IP) Management:

      • Oversee investigational product inventory and ensure proper storage, security, and handling per protocol.
      • Verify IP dispensation and administration, ensuring the accuracy of blinded or randomized information.

    4. Regulatory and Archiving:

      • Regularly review and update the Investigator Site File (ISF) for accuracy and completeness.
      • Ensure all essential documents are archived in accordance with local guidelines and regulations.

    5. Monitoring Activities and Reporting:

      • Document all site visits and activities in trip reports, communication logs, and other required documents.
      • Ensure compliance with project timelines, budgets, and scope. Track observations and action items through tracking systems.
      • Support subject recruitment, retention, and awareness strategies.

    6. Collaboration and Training:

      • Serve as the primary liaison between study site personnel and the project team.
      • Prepare for and attend Investigator Meetings and sponsor meetings, ensuring alignment with project objectives and goals.
      • Provide training to site personnel and junior staff as needed.

    7. Audit Readiness and Site Support:

      • Maintain audit readiness and provide support for audit preparation and follow-up actions.

    8. Real World Late Phase (RWLP) Responsibilities:

      • Provide support throughout the study lifecycle, from site identification through close-out.
      • Participate in chart abstraction, data collection, and collaborate with local teams, medical science liaisons, and affiliates.
      • Identify out-of-scope activities and proactively suggest potential sites based on local treatment patterns and healthcare provider knowledge.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Experience: Proficient knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements. Minimum 2 years of experience as a Clinical Research Associate.
    • Skills:
      • Strong computer skills and an ability to embrace new technologies.
      • Excellent communication, presentation, and interpersonal skills.
      • Ability to travel up to 75% of the time as needed.

    Why Work at Syneos Health?

    Join a company that has been integral in working with 94% of FDA-approved novel drugs and 95% of EMA-authorized products. Syneos Health offers a dynamic, global environment where you can grow professionally and make a meaningful impact on patients' lives. Take your career to the next level with Syneos Health, where work truly matters everywhere.

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