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    Sponsor Dedicated Cra Ii - Home Based Portugal

    Syneos Health
    3-5 years
    Not Disclosed
    10 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

    Sponsor Dedicated Clinical Research Associate II - Home Based Portugal

    Company Overview: Syneos Health® is a leading biopharmaceutical solutions organization committed to accelerating customer success. By translating unique clinical, medical affairs, and commercial insights into real-world outcomes, Syneos Health addresses modern market challenges. With a focus on innovation and collaboration, we place the customer and patient at the center of everything we do, striving to simplify and streamline clinical development processes to make a difference in patients' lives.

    Why Syneos Health? We invest in the development of our people through career growth, continuous training, and a supportive work environment. We are driven by a Total Self culture where authenticity and diversity are celebrated, ensuring every employee feels valued and part of something greater. As a part of Syneos Health, you will have the opportunity to make a meaningful impact while working in a dynamic, inclusive environment.

    Key Responsibilities:

    1. Site Management and Monitoring:

      • Conduct site qualification, initiation, interim monitoring, and close-out visits (both on-site and remotely) ensuring compliance with ICH-GCP, GPP, and study protocols.
      • Use judgment to assess site performance, escalating serious issues to the project team and developing action plans as needed.
      • Verify informed consent procedures are properly executed and documented, ensuring patient confidentiality and safety.

    2. Clinical Data Integrity:

      • Perform Source Document Review (SDR) and verify clinical data in the case report form (CRF) to ensure completeness and accuracy.
      • Resolve data queries remotely and on-site, guiding site staff to ensure timely resolution.
      • Ensure site compliance with electronic data capture (EDC) requirements and utilize available software for effective data capture and review.

    3. Investigational Product (IP) Management:

      • Perform inventory and reconciliation of investigational products, ensuring they are handled and administered according to study protocols.
      • Ensure IP is properly labeled, imported, and stored, and manage risks associated with blinded or randomized information.

    4. Documentation and Reporting:

      • Document all monitoring activities through trip reports, communication logs, and follow-up letters as required.
      • Track observations, ongoing statuses, and action items in tracking systems to ensure progress and resolution of issues.
      • Maintain the Investigator Site File (ISF) and ensure all essential documents are archived in accordance with local regulations.

    5. Collaboration and Communication:

      • Act as the primary liaison with study site personnel or collaborate with the Central Monitoring Associate.
      • Prepare for and attend Investigator Meetings and sponsor meetings, ensuring alignment with project objectives and timelines.
      • Support recruitment, retention, and awareness strategies for study subjects.

    6. Audit Readiness and Site Support:

      • Provide guidance towards audit readiness and support preparations for audits and follow-up actions.
      • Ensure that all assigned sites and project team members are properly trained and compliant with applicable requirements.

    7. Real World Late Phase (RWLP) Responsibilities:

      • Manage site support across the study lifecycle, from site identification to close-out, with a focus on late-phase study designs.
      • Engage in chart abstraction and data collection, and collaborate with medical science liaisons, local staff, and sponsors.
      • Identify potential sites and provide local insights on treatment patterns and healthcare provider networks.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
    • Experience: A minimum of 2 years’ experience as a Clinical Research Associate, with a solid understanding of ICH-GCP Guidelines and regulatory requirements.
    • Skills:
      • Strong computer literacy and adaptability to new technologies.
      • Excellent communication, presentation, and interpersonal skills.
      • Ability to manage up to 75% travel for site visits and monitoring activities.

    Why Work at Syneos Health?

    At Syneos Health, you will be part of a global network that has worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. With a focus on innovation and collaboration, you'll have the opportunity to contribute to groundbreaking clinical research while advancing your own career in an environment that encourages continuous learning and personal growth. Join Syneos Health and make an impact on the lives of patients worldwide.

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